Solution Architect

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

Manager/ AVP – Corporate clients

Signal Integrity Test Technician

Japanese Senior Recruiter

Account Executive - Conglomerates and PSU 

Product Manager - Laser Processed Components

Senior Quality Specialist

Responsibilities: Solution Design <ul><li>Create architecture diagrams</li><li>Conduct technical feasibility analysis to ensure scalability, automation &amp; stability</li><li>Define impacted systems &amp; proactively solve issues in architecture design</li><li>Ensure alignment with principles, guidelines and standards</li><li>Prepare documentations for AWG sign off</li></ul> Solution Implementation <ul><li>Provide timely feature implementation support to vendor Analyze and translate business requirements to technical solutions</li><li>Deliver back-end architecture integration plan</li><li>Ensure implementation is performed according to plan</li><li>Identify risks, assess their potential impact, and develop risk management strategies</li></ul> Technical Guidance and Support <ul><li>Propose tech solutions and resolve architectural ambiguities</li><li>Establish opportunities, constraints and trade off for tech architecture/ solutions</li><li>Communicate technical dependencies and requirements with other domain architects</li></ul> Documentation and Reporting <ul><li>Work closely with PMO and Lead to prepare reports for stakeholders and leadership, that communicate the integration progress, risks and issues</li><li>Document issues, decisions and outcomes throughout the migration process</li></ul> Requirements: <ul><li>Degree holder in Information Technology, Info Systems or equivalent.</li><li>Fluent Chinese/Mandarin in speaking is required.</li><li>Minimum 3 years of experience as a System Architect</li><li>Minimum 3 years of experience in Solution design with modern architectures not limited to SOA, Microservice, Serverless, Cloud/Cloud Hybrid.</li><li>Experiences in project management and vendor management.</li><li>Experiences in Spring Cloud development in Java, experience in AWS is a plus.</li><li>Experiences in databases such as SQL (MySQL, PostgreSQL) or NoSQL (MongoDB) databases.</li><li>Experiences in front-end frameworks/technologies such as AngularJS, ReactJS and Node.JS is an added advantage.</li><li>Strong capability of trouble-shooting on enterprise application defects and performance issues for both Cloud and on-premise applications.</li><li>Familiar with CICD DevOps and DevSecOps, also familiar with tools like Github, Jenkins pipelines.</li><li>Must be able to communicate effectively with China vendor.</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.</li><li>Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.</li><li>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Responsibilities: <ul><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices / pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li></ul> Requirements: Skills and Qualifications: <ul><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.</li><li>Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage</li><li>Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.)</li><li>Excellent project management and organizational skills</li><li>Ability to analyze and interpret complex regulations</li><li>Proficient in regulatory writing and submission tools</li><li>Strong communication and interpersonal skills</li><li>Ability to manage multiple projects and meet deadlines.</li></ul> Experience : <ul><li>7-10 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals</li><li>Experience in handling registration of Medical Devices and getting approval.</li></ul>

Responsibilities: <ul><li>Preparation of documentation and conduct CDD in a timely manner</li><li>To liaise with Relationship Managers on the required documentation</li><li>Ensure that ongoing CDD reviews are conducted in tandem with internal process and policies</li><li>Ensure data accuracy in systems and documentations</li><li>Extraction of data from worksheets and reports for distribution to respective Business segments for necessary follow-up actions</li><li>Assisting BUs to respond to various CDD enquiries, which may originate from the local authorities or from correspondent banks, over client’s profile</li><li>Perform screening assessment and escalate material hits, where applicable for further clearance.</li><li>Assisting the Team Leader in providing regular statistics and presentations for updating to Senior Management</li><li>Participating in ad-hoc assignments and projects, e.g., audit, user acceptance testing etc. where required</li><li>Providing advisory support to the BUs in CDD related matters, where applicable</li></ul> Requirements:﻿ <ul><li>Degree holder and above</li><li>Detail-oriented, yet able to think flexibly and independently to resolve problems</li><li>Maintaining a high degree of knowledge in MAS 626 regulations and associated regulatory requirements for AML/CFT and Sanctions</li><li>Handling data, and able to perform functions on Excel, such as Vlookup, Pivoting and generating various graphs / charts, etc</li><li>Certification as an AFC specialist (e.g., CAMS / Diploma in AML, Governance and Risk) with a recognized institution will be an advantage</li></ul>&nbsp;

Responsibilities: NPI Bulk Cable SI test: <ul><li>Follow Bulk cable SI test procedures to prepare fixture.</li><li>Follow Bulk cable SI test procedures to test bulk cables.</li><li>Check and confirm the SI test result</li></ul> Make NPI Bulk Cable SI test Report: <ul><li>After the test is done, summary the report and feedback to bulk cable PDE and MPDE</li></ul> Bulk Cable Physical data confirm: <ul><li>Confirm the physical test data with lab as a field representative if bulk cable PDE &amp; MPDE have concerns about the data</li></ul> Requirements: Education, Technical Qualification &amp; Experience: <ul><li>High school and above</li><li>Familiar with office software</li><li>Experience with high speed cable/cable assembly test</li><li>Experience with high speed test equipment (Digital Sampling Oscilloscope, Vector Network Analyzer, Bit Error Rate Tester, TDR, Pattern Generators, Power Supplies, etc.)</li><li>Have capabilities to interpret test/lab data to identify issues</li></ul>

Responsibilities: <ul><li>End-to-End Recruitment: Manage the entire recruitment process for a variety of positions, from sourcing and interviewing to offer negotiation and onboarding.</li><li>Talent Sourcing: Utilize a variety of channels (LinkedIn, job boards, networks) to identify and attract top candidates. You will also leverage your personal network within Japan to help identify high-quality candidates.</li><li>Candidate Screening: Conduct in-depth interviews to evaluate candidates technical and cultural fit for roles.</li><li>Stakeholder Management: Partner with hiring managers to understand hiring needs, provide regular updates, and advise on talent trends and market conditions in Japan.</li><li>Market Expertise: Be a subject matter expert in recruiting for roles in Japan and stay updated on the latest hiring trends and compliance regulations.</li><li>Relationship Building: Cultivate strong relationships with candidates and hiring managers to ensure a smooth and positive hiring process.</li><li>Reporting &amp; Metrics: Maintain and track recruitment data, providing regular reports on the progress of hiring activities, as well as contributing to improvements in the recruitment process.</li></ul> Requirements: <ul><li>Experience: Minimum of 5 years of recruiting experience, with a focus on hiring for positions based in Japan. Familiarity with the Japanese job market and recruitment practices is essential.</li><li>Language Skills: Fluent in Japanese (native-level or near-native) and strong communication skills in English.</li><li>Expertise: Proven experience in recruiting for a variety of roles (technical, non-technical, and leadership positions). Experience hiring for multinational companies is a plus.</li><li>Candidate Sourcing: Strong skills in using various sourcing tools and channels, including LinkedIn, job boards, and personal networks, to identify top talent.</li><li>Remote Work: Comfortable working remotely, with strong time management and communication skills to collaborate effectively across teams.</li><li>Cultural Fit: A deep understanding of Japanese business culture and the ability to assess cultural fit for potential hires.</li></ul>

Responsibilities: <ul><li>Handle and grow relationships with key stakeholders and C-level executives in large conglomerates and PSUs.</li><li>Develop and execute strategic account plans that align with customer business objectives and solutions portfolio.</li><li>Lead the end-to-end sales cycle for large, complex deals, including opportunity identification, proposal development, negotiation, and closure.</li><li>Demonstrate strong achievement orientation by consistently meeting or exceeding sales targets and business goals.</li><li>Collaborate closely with cross-functional teams including Solutions Engineers, Premium Services sellers, and Channel Partners to deliver integrated solutions.</li><li>Utilize data analytics and market insights to identify upsell and cross-sell opportunities within assigned accounts.</li><li>Represent at industry forums and client executive meetings to enhance brand presence and influence.</li><li>Maintain accurate and timely sales forecasts, pipeline management, and account reporting.</li></ul> Requirements: <ul><li>Minimum 11 years of experience in account management or sales, specifically managing large conglomerates and PSUs.</li><li>Proven track record of constructing and closing large, strategic deals.</li><li>Strong achievement orientation with a history of consistently exceeding sales targets.</li><li>Deep understanding of the Indian corporate and government sectors, with established relationships at senior levels.</li><li>Exceptional communication, negotiation, and interpersonal skills.</li><li>Ability to work independently and lead cross-functional teams in a dynamic environment.</li><li>Based out of Mumbai with willingness to travel as required.</li></ul>

Responsibilities: Market Sensing &amp; Strategy Development <ul><li>Understand and articulate market and industry trends, demand drivers, customer needs, and competitive landscape.</li><li>Define application and market segment–specific value propositions that beat competition.</li><li>Develop product roadmaps and manage product lifecycle that aligns with business strategy.</li><li>Design go-to-market strategy, inclusive of channel strategy and partnerships.</li></ul> Develop Business Plan <ul><li>Define resource and investment needs necessary to execute the product roadmap and growth strategy.</li><li>Work cross-functionally to define sales, R&amp;D, and operations strategies and goals, in line with financial goals. Build consensus on specific tasks.</li><li>Establish pricing policy aligned with business and product strategy.</li><li>Develop the annual operating plan (Sales and gross or standard margin).</li></ul> Execution – New Product Development &amp; Launch <ul><li>Be the opportunity champion for development projects – exercise thought leadership to drive product innovation.</li><li>Plan product launches, including the development of marketing and sales plans, and competitive, market-based pricing.</li><li>Provide demand forecast inputs to S&amp;OP.</li></ul> Execution – Growth and Product Lifecycle Management <ul><li>Manage P&amp;L for the portfolio to deliver sustained profitable growth, with a strong bias for action.</li><li>Enable sales teams for pipeline growth and conversion through training, value-proposition development, customer engagement, etc.</li><li>Manage special price requests and ongoing competitive benchmarking.</li><li>Track progress to the business plan and be the champion for resolution of product issues and gaps (e.g., quality, delivery, etc.).</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s degree; advanced business degree (MBA) preferred.</li><li>8+ years of product management, sales, business development or relevant P&amp;L management experience.</li><li>Metal laser processing product experience in industrial markets or Medical, highly preferred.</li><li>Experience in Medical devices sector with OEMs or Tier 1 supplier, highly preferred.</li><li>Managing and motivating others, and building high-performing teams cross-functionally.</li><li>Strong business acumen and able to navigate technically complex concepts.</li><li>Creative and innovative thinker able to provide input on the development of the product strategies and relevant business plans with the ability to execute.</li><li>Proven ability to multi-task and drive results in a dynamic, high-paced environment.</li><li>Strong interpersonal, planning, organization, and teamwork skills.</li><li>Ability to influence cross functional teams both internally and externally.</li><li>Advanced presentation skills with the ability to effectively communicate complex concepts to foster understanding and acknowledgement of critical information both up and down the organization.</li></ul>

Responsibilities: <ul><li>Point of Contact for all quality matters, enquiries, and support to both internal and external customers</li><li>Develop, implement and align quality strategies to ensure processes and procedures meet quality excellence standards</li><li>Lead and mentor colleagues at sales operations offices, fostering a culture of excellence and accountability</li><li>Oversee the management of ISO 9001:2015 and quality system (CAPA, Change Management, Investigation, etc.)&nbsp;</li><li>Manage, own and investigate product complaints</li><li>Business Process Owner for Document Control</li><li>Analyse and track quality metrics such as Complaint KPI</li><li>Conduct/Host audits (internal and external) and inspections to ensure compliance with regulatory, quality and internal standards</li><li>Manage and negotiate quality agreements with end customers, group legal and global quality&nbsp;</li><li>Support quality documentation requests from customers</li><li>Ensure documentation and traceability of quality processes and corrective actions</li><li>Facilitate quality management reviews and relevant quality meetings</li><li>Manage supplier quality and conduct vendor assessments when necessary</li><li>Collaborate with cross-functional teams (e.g., global supply, sales, global quality, support teams) to resolve quality issues</li><li>Stay updated on industry trends, standards, and regulatory changes (where required)</li><li>Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree in Biological Sciences, Quality Engineering, or related fields</li><li>5+ years of experience in quality assurance, quality compliance, supplier quality or quality operations&nbsp;</li><li>Strong knowledge of QA methodologies, tools, and standards (e.g., ISO 9001:2015, ISO 13485, cGMP/GxP relevant)</li><li>Auditor certification in quality standards preferred</li><li>Strong knowledge in investigation and RCA methodology, and technical writing skills</li><li>Proficiency in quality management systems softwares (e.g., Trackwise)</li><li>Excellent analytical, problem-solving, and decision-making skills</li><li>Strong communication and interpersonal skills</li><li>Able to work in fast-paced, dynamic environments</li><li>Detail-oriented with a strategic mindset</li><li>Independent, Proactive and Task-driven</li><li>Leadership experience preferred</li></ul>

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204 software request management Jobs found

Solution Architect

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

Manager/ AVP – Corporate clients

Signal Integrity Test Technician

Japanese Senior Recruiter

Account Executive - Conglomerates and PSU

Product Manager - Laser Processed Components

Senior Quality Specialist

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Skills

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204 software request management Jobs found

Solution Architect

Director, Engineering Services

Manager, Operations

Regulatory Affairs Manager

Manager/ AVP – Corporate clients

Signal Integrity Test Technician

Japanese Senior Recruiter

Account Executive - Conglomerates and PSU

Product Manager - Laser Processed Components

Senior Quality Specialist

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.