Site Investigation Lead, Quality Assurance

SAP B1 Master Data and Process Improvement Specialist

Test Engineer (Signal Integrity)

Solution Architect – WIFI

Staff Engineer – Devices

Data Quality Engineer

Supply Chain Finance Analyst

Manager M&A Integrations/Separations EMEA

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><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><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities 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><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</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>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is 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>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Job Summary: <ul><li>We are seeking a highly skilled and motivated SAP B1 Master Data and Process Improvement Specialist to join our team in Kuala Lumpur.</li><li>This role will be responsible for managing and optimizing the master data processes within SAP Business One (SAP B1), as well as identifying and implementing process improvements across various functions.&nbsp;</li><li>The ideal candidate will have strong SAP B1 experience, with a keen eye for data accuracy and process efficiency.</li></ul> Responsibilities: SAP B1 Master Data Management: <ul><li>Oversee and manage the creation, maintenance, and validation of master data in SAP B1 (customers, vendors, items, etc.).</li><li>Ensure data accuracy and consistency across all systems and processes.</li><li>Develop and maintain data governance procedures for SAP B1 to ensure compliance with internal and external requirements.</li><li>Act as the primary point of contact for SAP B1 master data issues and support.</li><li>Coordinate with cross-functional teams to ensure data quality in SAP B1.</li></ul> Process Improvement and Optimization: <ul><li>Analyze existing business processes and identify opportunities for improvement in efficiency, cost-effectiveness, and data accuracy.</li><li>Lead initiatives to streamline processes, focusing on automation and reduction of manual interventions.</li><li>Collaborate with stakeholders across departments to define process improvement goals and implement solutions.</li><li>Conduct workshops and training sessions to ensure the adoption of improved processes and systems.</li><li>Monitor the effectiveness of implemented changes and adjust processes as necessary.</li></ul> Collaboration and Support: <ul><li>Work closely with the SAP B1 development team and other internal departments to ensure integration of master data management and process improvements.</li><li>Provide training and guidance to end-users to enhance their understanding of SAP B1 and best practices in data management.</li><li>Document and share lessons learned, process improvements, and best practices with the broader team.</li></ul> ﻿Requirements: <ul><li>Bachelors degree in Information Technology, Business Administration, Accounting, or related field.</li><li>Chartered Accountant qualification (ACA, ACCA, or equivalent) is preferred.</li><li>Minimum 3-5 years of experience working with SAP Business One (SAP B1).</li><li>Proven track record in managing master data processes within SAP B1.</li><li>Strong understanding of business process analysis and improvement techniques.</li><li>Experience in process mapping, process redesign, and implementation of process improvements.</li><li>Ability to work in a fast-paced environment and manage multiple priorities.</li><li>Excellent communication skills, both written and verbal.</li><li>Strong analytical and problem-solving skills.</li><li>Ability to work independently and in a team environment.</li><li>Fluency in English is required; proficiency in Bahasa Malaysia is a plus.</li></ul> Additional Qualifications: <ul><li>Certification in SAP B1 or related process improvement methodologies (Lean, Six Sigma, etc.).</li><li>Experience in project management and change management is a plus.</li></ul>

Responsibilities: <ul><li>Develop and execute a signal integrity test and validation plan, including scope, schedule estimation, and resource allocation for server, storage, and&nbsp;</li><li>communication platforms.</li><li>Conduct signal integrity and power integrity simulations and analysis at the system level for high-speed digital systems.</li><li>Perform hands-on electrical/design validation and compliance testing using high-speed oscilloscopes, TDR (Time-Domain Reflectometry), VNA (Vector&nbsp;</li><li>Network Analyzer), probe stations, and other relevant test instruments.</li><li>Manage the SI test room conditions, ensuring compliance with ESD (Electrostatic Discharge) requirements.</li><li>Maintain SI test equipment, including network analyzers, TDRs, jigs, and fixtures, ensuring they are in good working condition and stock levels are sufficient to support production.</li><li>Analyze signal integrity failures and provide recommendations for design and process improvements.</li><li>Collaborate with cross-functional teams, including PCB layout engineers, hardware engineers, and system architects, to optimize SI performance.</li><li>Troubleshoot SI-related issues and develop mitigation strategies for high-speed digital designs.</li><li>Document and present analysis results, recommendations, and test reports to relevant stakeholder</li></ul> ﻿Requirements: <ul><li>Bachelor’s degree in engineering (Electrical, Electronics, or related field).</li><li>7-8 years of experience in signal integrity testing, validation, power integrity and analysis.</li><li>Hands-on experience with network analyzers, TDR operations, high-speed oscilloscopes, probe stations, and other signal integrity test instruments.</li><li>Strong understanding of transmission line theory, impedance matching, crosstalk mitigation, and high-speed design constraints.</li><li>Experience managing SI test lab environments, including ESD compliance and equipment maintenance.</li><li>Knowledge of high-speed interfaces such as PCIe, USB, DDR, Ethernet, and SERDES technologies.</li><li>Strong analytical and problem-solving skills.</li><li>Excellent communication and teamwork abilities.</li></ul>

Responsibilities: <ul><li>Be part of the APAC SA/L3 team supporting regional and global projects on wireless planning</li><li>Work alongside R&amp;D engineers for Wireless Communications.</li><li>Take the lead in wireless planning for network, security and site installation in factories, plants, campuses and hospitality buildings.</li><li>Require working on-site for survey and fine-tuning.</li><li>Document and visualize wireless network designs in the form of design prerequisites, topology drawings, reports, configuration procedures, performance metrics, and demonstrations.</li><li>Validating designs in the company Customer Innovation Center (CIC) lab with the company GPS team including validation of company technology with third-party products.</li><li>Reporting projects and customers’ feedback to Sales, Product Management, and company Engineering/R&amp;D</li></ul> Requirements: <ul><li>Education - 6-10+ years of experience in Wireless Network engineering, design, and implementation.</li><li>Background in Engineering is a must (Computer/Electrical/Electronics/Wireless/Communication Engineering).</li><li>Markets - Strong Knowledge of Wireless and relevant cyber security technologies, Wireless Engineering Research and Development with an ability to Wi-Fi standards &amp; antennas and should be able to diagnose complex wireless networks with considerations in RF environment and provide in depth analysis and design guidance.</li><li>Technical know-how in Industrial Ethernet and technologies like SCADA Industrial Control Systems, Digital Automation, Industrial Cyber Security, Cloud Computing, Industrial Networking &amp; AutoCAD drawing is a plus.</li><li>Customers Define our Success – Results-oriented with a process mindset. Excellent interpersonal and communication skills with strong ownership &amp; should be comfortable with communication/engagement with customers and partners. </li><li>Willing to dedicate extra time and travel to meet objectives.&nbsp;</li></ul>

Responsibilities: Design &amp; Development: <ul><li>Lead the design and development of drug combination products by understanding design space and managing critical design parameters.</li><li>Utilize SolidWorks and apply design for manufacturing (DFM) principles along with geometric dimensioning and tolerancing (GD&amp;T) to create sound engineering drawings.</li><li>Identify the best tools and approaches to effectively solve engineering problems.</li><li>Develop, optimize, and analyze designs using a combination of engineering principles, analytical methods, and experimental techniques.</li></ul> Technical Support &amp; Compliance: <ul><li>Support the evaluation and assessment of new technologies, intellectual property, products, and processes.</li><li>Provide support for existing products in terms of quality, manufacturing, and cost improvement.</li><li>Execute technical and cross-functional project work to ensure successful product development.</li><li>Develop and implement detailed test methods and write comprehensive technical reports based on design verification testing for design changes and product design activities.</li><li>Collaborate effectively with laboratory technicians and support staff.</li><li>Ensure compliance with quality policies, standard operating procedures, and regulatory requirements.</li></ul> Requirements: Regulatory &amp; Validation Expertise: <ul><li>Knowledge of Factory Acceptance Testing (FAT), Process Validation, and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ).</li><li>Understanding of U.S. regulatory and quality requirements, including 21 CFR 820.3</li></ul> Experience: <ul><li>Minimum 8 years of engineering experience, with a preference for at least 5 years in product development.</li><li>Strong understanding of disciplined product development processes and quality requirements.</li><li>Experience in statistical tools, computer analysis, and engineering fundamentals for problem-solving.</li><li>Proficiency in SolidWorks is required.</li></ul> Skills &amp; Competencies: <ul><li>Strong interpersonal skills with the ability to collaborate effectively.</li><li>Excellent technical judgment and problem-solving abilities.</li><li>Demonstrated accountability for the successful completion of assigned tasks.</li></ul>

Responsibilities: <ul><li>Accountable for DQ Solution Build, Test, and Deploy using Informatica Cloud Data Quality (IDMC).</li><li>Develop, Review, maintain codebase in accordance with industry best practices and standards.</li><li>Support for DQ solution related Job or Task failures, Root cause analysis &amp; fixes the issues.</li><li>Closely work with DQ SMEs to implement DQ rules to measure and Report Data Quality.</li><li>Fundamental in Informatica IDMC services – Data Quality (CDQ), Data Integration (CDI), Address Doctor/AD6, and Profiling.</li><li>Data Extraction, Data validation and Reports generation for Batch &amp; Real-time.</li><li>Data Profiling, DQ Rule creation and DQ Scorecard generation.</li><li>Handle basic issues and problems under direct supervision, while escalating more complex issues to appropriate staff.</li></ul> Requirements: <ul><li>Bachelor’s degree in a related field or equivalent experience</li><li>Minimum 3-6 years of experience in Informatica Cloud Data Quality Platform/ solutions (IDMC).</li><li>Other minimum qualifications may apply.</li><li>IDMC - Cloud Data Quality (CDQ), Data Integration (CI), Profiling – Mandatory</li></ul>

Responsibilities: <ul><li>Become the main finance counterpart to provide long term P&amp;L impacts of COGS efficiency/saving plans.</li><li>Track the delivery of saving plans to ensure COGS efficiency is delivered as per forecast.</li><li>Prepare COGS database and analysis from existing and future sourcing to find the most efficient sourcing.</li><li>Own and prepare annual-monthly budgeting of Supply Chain Losses.</li><li>Provide visibility and monthly commentary on SCL actual performance vs forecast/budget and define actions to improve.</li><li>Drive process improvement of SCL from claim visibility, validation, and external/internal resolution.</li></ul> Requirements: <ul><li>Education: Background Finance/ Business and Administration&nbsp;</li><li>Education Level: Bachelor’s Degree minimum</li><li>Working Experience: Minimum 2 years experience in Supply Chain Finance from FMCG Industry&nbsp;</li><li>Technical Skills: Strong analytical, forecasting, budgeting, cost and business analysis.</li><li>Other Specific Requirements: Good command of English&nbsp;</li></ul> Personality/ Attitude: <ul><li>Self-Driven with a strong sense of responsibility and initiative to drive changes for business improvement</li><li>Proactive and self-directed learner, eager to acquire new knowledge at a fast-paced environment</li><li>Capable of coping with pressure and deadline</li></ul>

Role Description:This specific position is for the Corporate Development team. The M&A Integrations/Separations Consultant EMEA position will lead projects and specific operational work streams related to a) the evaluation, planning and carve-out of targeted businesses in the portfolio and b) planning and execution of post-acquisition integration for acquisitions, to support the realization of our strategic and financial objectives.You will collaborate with various corporate functions and business units, incl. with senior executives, to achieve objectives of maximizing value in such transactions.Responsibilities:Separation Planning & Execution:Support initial validation to understand the operational, financial and legal complexity of a potential divestiture.Work closely with Corporate M&A and the business units to understand performance trends, stand-alone financial results, stranded costs and tax impact, gain approval, structure and program manage the process of actual separation.Provide thought leadership in defining and creating standalone operating models including viable and possible alternatives on sub-streams like core technology, organization structure, human capital, legal entity structure/formalities, commercial contracts (client and vendor), communications and change management.Work closely with the business, corporate functions and external providers in executing the separation and post-close activities including creating and managing detailed transition services arrangements where necessary.Manage the program: create, manage and report on the project plan spanning various streams, milestones, interdependencies from Day 1 to end of potential TSAs.Highlight ongoing risks and validate financials, especially stranded costs and options.Acquisition Integration:Create post-merger integration project plans: Day 1-100 planning, post-close medium-term implementation, transformation, organizational change priorities, communications, change management & performance tracking with a focus on realizing deal-book synergies and achieving top line revenue growth.Support/lead post-close implementation of key milestones as agreed in the integration plan.Identify key value drivers and help manage to achieve the required results, including adoption of best practices like pricing, sales management and digital marketing.Identify key risks and dependencies leading to slippage from deal-book: key talent attrition, salesforce churn, client attrition, migration of business services etc.Drive alignment between the new entity, the business unit and appropriate functions by assisting in designing/implementing the new organizational model.Analyze financial impact and drive alignment with business plan/budgets.Work with acquiring business units and corporate functions to execute and manage the plan, reporting on key milestones/metrics (financial and other) to help realize the synergies.Support due diligence efforts for key transactions to understand the business and its issues prior to close; working with the business and corporate M&A teams.Requirements: Minimum Requirements:5-7 years of hands-on experience in leading complex divestitures as well as post-merger integration for transaction sizes of $50-150MM in revenuesExperience in leading and managing multiple streams in dynamic and complex environment within the complete M&A life cyclePreferred Requirements:Experience as part of a corporate development team with operational exposure across primary corporate functions and domains (e.g., HR, IT, Procurement, Finance, Legal, etc.), AND / OR Experience within a bulge-bracket consulting firm within post-merger integration or divestiture planning and execution practice areasOther Requirements:Strong people leadership, process management and communications skills in multi-geography, multi-division environment is a plusStrong foundational consulting skills: analytical, written and verbal communication, problem solving, collaboration, change management and a bias towards execution and ownership of solutions.Occasional (10-25%) travel required.

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8 validation Jobs found

Site Investigation Lead, Quality Assurance

SAP B1 Master Data and Process Improvement Specialist

Test Engineer (Signal Integrity)

Solution Architect – WIFI

Staff Engineer – Devices

Data Quality Engineer

Supply Chain Finance Analyst

Manager M&A Integrations/Separations EMEA

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8 validation Jobs found

Site Investigation Lead, Quality Assurance

SAP B1 Master Data and Process Improvement Specialist

Test Engineer (Signal Integrity)

Solution Architect – WIFI

Staff Engineer – Devices

Data Quality Engineer

Supply Chain Finance Analyst

Manager M&A Integrations/Separations EMEA

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

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TALENT

COMPANY

Contact Us

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