Research Associate – II Nitrosamines

Manager – ADL GMP

CEO Executive Assistant

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Regional Employee Relations Manager

Regional Sales Manager - North Africa

Quality Senior Lead

Accountant

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Responsibilities: <ul><li>Manage CEO’s calendar, travel plans, agendas, and correspondence, including confidential materials.</li><li>Serve as the primary liaison between the CEO, board members, senior management, and external stakeholders.</li><li>Organize and prioritize requests, provide recommendations, and make decisions aligned with the CEO’s style and organizational policies.</li><li>Oversee special projects, ensuring seamless execution and effective communication.</li><li>Draft correspondence, acknowledgment letters, and materials to support CEO operations.</li><li>Maintain CEO profile and represent the CEO in internal and external communications.</li><li>Assist with hospitality and logistical arrangements for board members and guests.</li><li>Track project progress, customer satisfaction, and risk mitigation strategies.</li></ul> Requirements: <ul><li>Bachelor’s degree or equivalent experience.</li><li>5–10 years supporting C-level executives.</li><li>Expert proficiency in Microsoft Office and desktop publishing software.</li><li>Strong organizational, time-management, written, and verbal communication skills.</li><li>Ability to manage competing priorities independently, maintain discretion, and work professionally with diverse stakeholders.</li></ul>

Role Description: <ul><li>The MPDE Automation Manager will lead a team of automation engineers tasked with developing assembly processes for high-speed cable assemblies and coordinating with the Thailand manufacturing engineering team on the transition to mass production.</li></ul> Responsibilities: Lead a team of engineers who will: <ul><li>Develop cable assembly automation lines in accordance with LEANPD product development.</li><li>Drive for excellence in existing automation technologies and methods.</li><li>Strive to implement new automation technologies to provide improved process and tolerance control.</li><li>Support Product Development in the optimization designs (DFM) and piece parts for automation manufacturability.</li><li>Realizes proof of concept tooling, product samples and prototypes.</li><li>Act as the binding element between product development and automation engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Maintain communication with project management team to understand current and future strategic business needs.</li><li>Prioritize and time manage a portfolio of projects/work efforts based on criticality and business need.</li></ul> Requirements: <ul><li>Bachelor or above degree with mechanical/electric related majors.</li><li>At least 5 years related experience managerial level in multinational manufacturing site.</li><li>Familiar with Lean, Six Sigma. etc. industrial methods/tools.</li><li>With 2 years or above work experience in cable assembly automation is preferred.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Lead and manage employee relations activities within the IMEA region, ensuring timely and fair case resolution in alignment with global ER policies and practices.</li><li>Provide direct ER leadership over the India business in particular, as the largest business in the region.</li><li>Support labor/industrial relations strategy across the region, including union engagement, worker committee processes, and required consultation protocols under local law.</li><li>Serve as the primary escalation point for complex and high-risk ER cases, partnering with Legal and other stakeholders as needed.</li><li>Directly manage ER case intake, investigation, resolution, and closure, ensuring a consistent, professional colleague experience across the region.</li><li>Partner with regional Business-Facing HR teams to deliver hybrid ER support where needed, especially in countries with minimal headcount or unique legal complexity.</li><li>Provide day-to-day direction and mentorship to regional ER Advisors, ensuring professional service delivery, skill development, and workload balance.</li><li>Monitor case trends, emerging risks, and workforce issues, delivering actionable insights and recommendations to regional and global leadership.</li><li>Execute the Employee Relations annual governance cycle within the region, including quarterly campaign delivery, stakeholder reporting, and process audits.</li><li>Ensure full adoption of ER case management protocols in ServiceNow, including accurate logging, escalation, documentation, and timely case closure.</li><li>Deliver coaching and education to site leaders on performance management, conflict resolution, workplace expectations, and policy application.</li><li>Collaborate on global ER projects and initiatives, bringing IMEA-specific insights to shape global practices, policies, and processes.</li><li>Support leaders to foster a fair, consistent, and compliant employee experience aligned with our client People Plan.</li></ul> Requirements: <ul><li>Education: Bachelor’s degree in Human Resources, Business Administration, or a related field; Master’s degree preferred.</li></ul> Experience: <ul><li>7+ years of experience in employee relations or HR, including regional or global support experience.</li><li>5+ years of employee relations or HR experience in India</li><li>3+ years managing complex employee relations cases required.</li><li>Experience working in a centralized Employee Relations delivery model preferred.</li></ul> Skills:&nbsp; <ul><li>Strong leadership and delegation skills, excellent problem-solving and conflict resolution skills, team leadership experience, and expertise in handling escalated cases and performance improvement processes.</li><li>Proficiency in English and Marathi required; additional languages based on region are a plus (e.g., Arabic, Hindi, French).</li></ul>

Responsibilities: Market and customer development assessment <ul><li>Provide market, regulatory, customer and competition landscape: outlook, insights and 5 years forecast&nbsp;</li><li>Conduct research of cigarettes manufacturers in Africa and intelligence on manufacturing production volume and consumptions</li><li>Conduct research of customer products, key buying factors and next best alternatives</li><li>Insights and updates on Sanctions, Regulatory, government intervention e.g. taxation, bans [Content and what it means to Our client]&nbsp;</li><li>Consumer and product research: Conventional cigarettes type [format, brand board, types of tobacco, exports and imports distribution channels]&nbsp;</li><li>Consumer and product research: Reduced Risk Product (RRP) / Next Generation Product (NGP) cigarettes type [format, brand board, types of tobacco, exports and imports distribution channels]&nbsp;</li><li>SWOT analysis</li><li>Sourcing needs: what are the roadblocks and what is require?&nbsp;</li><li>Appetite for new product launches.</li><li>How does the deal work for IMB, BAT who sold their business but has opportunity to reengage after 2/3 years?</li><li>Secure meetings for Our client with targeted customers including Top to Top meeting</li><li>Assess opportunity to work with traders&nbsp;</li><li>Market trend analysis and competitor activity in region</li><li>Effective market and customer reporting</li></ul> Customer Management&nbsp; <ul><li>Comprehensive understanding of customers’ market dynamics, segments and trends</li><li>Co-ordination of sales activity to maximise sales opportunities</li><li>Maintain relationships with customers, prospects and participate in key customer meetings</li><li>Develop support tools and support cross functional to provide customer ease of working&nbsp;</li><li>Customer Strategy, Plan and implementation&nbsp;</li><li>Sustainable customer lifetime growth</li><li>Prepare sales contracts ensuring adherence to law-established rules and guidelines</li><li>Effective and relevant customer meetings</li><li>Annual customer relationship contact plan</li><li>Effective delegation of activity within team</li><li>Cross functional team mapping [between customers and Our client team] and secure cross business engagement</li><li>Ensure thorough and disciplined use of key tools aligned with Our client Ruby framework</li><li>Monthly Performance Dashboard to track progress, with year-end projections and SMART action plans in Opportunity Pipeline Tracker</li><li>Continuous Review of customer performance versus the annual plan and budget with creation of action plans to address under performance</li></ul> Sales Planning and Development&nbsp; <ul><li>Promote Our client value proposition and market presence</li><li>Promote and sell Our client solutions by establishing key contacts and developing relationships with target customers</li><li>Generate new enquiries from existing customers, prospecting of new customers within Africa&nbsp;</li><li>Identify and create new opportunities to deliver growth in revenue and profitability&nbsp;</li><li>Management of sales pipeline through Opportunity Pipeline Tracker</li><li>Create and implement Africa’s 5 years strategy plan</li><li>Delivery of market segmentation matrix</li><li>Longer term product lifecycle considerations [Dual sourcing strategy for existing SKUs, and in-house avoidance]&nbsp;</li><li>Ensure thorough and disciplined use of Opportunity Pipeline Tracker</li><li>Our client solutions [Scientific services included] mapping across customers and market&nbsp;</li><li>Secure innovation session with brand owners and decision makers</li><li>Market trend analysis and competitor activity in region</li><li>Longer term product lifecycle considerations</li><li>Effective market and customer reporting</li><li>Monthly Performance Tracker to track progress</li><li>Accurate forecasting and Monthly reporting&nbsp;</li><li>Tracking performance through Salesforce.com</li></ul> Requirements: <ul><li>Bachelor’s degree in business or equivalent discipline</li><li>At least 10 years of sales and account management experience with a minimum of 5 years prior experience in the tobacco industry (must have)</li><li>Fluent in English (both written and spoken) and nice to have local African languages</li><li>Excellent coordination and communication skills to address internal and external teams</li><li>Ability to travel frequently internationally to meet partners and customers</li><li>Excellent analytical skills; Energetic self-starter possessing self-confidence and maturity&nbsp;</li><li>Very good presentation skills and attention to detail&nbsp;</li><li>Passion for sales and business growth&nbsp;</li><li>Project management skills</li><li>Highly self-motivated, ambitious, resourceful and driven</li><li>Excellent leadership, influencing and listening skills</li><li class="ql-align-justify">Good understanding of business processes, including sales, supply chain and customer service</li></ul>

Role Description: <ul><li>Work with Parts leadership team to develop Quality system for Parts operations and implement.</li><li>Drive quality improvements in Receiving, storage, Packaging and shipping.</li><li>The position will be responsible for both Product quality and process quality.</li><li>The position will also oversee quality awareness program to educate and empower teams to drive quality function in their departments.</li></ul> Responsibilities: <ul><li>Develop and implement robust quality assurance processes for incoming, in-process, and outgoing tractor spare parts.</li><li>Conduct inspections and audits to ensure adherence to company and industry standards using Demerit system.</li><li>Collaborate with suppliers to maintain the quality of purchased parts.</li><li>Manage dealer return and claim management including issuance of credit notes to customers.</li><li>Drive quality awareness program to improve skill levels of warehouse teams with respect to Quality.</li><li>Mistake proof processes to ensure zero defects flowing to customer.</li></ul> Requiresments: <ul><li>Quality management experience of 2 – 3 years is preferred</li><li>Experience / exposure to best practices for packaging of spare parts in warehousing environment.</li><li>Exposure and experience in use of quality tools like APQP, FMEA, and SPC will be plus.</li><li>Understanding of Lean six Sigma Principles</li><li>Must be Proficient in Microsoft Excel, Outlook and SAP</li><li>Excellent data analysis skills and analytical mindset</li><li>Ability to work in a team environment</li><li>Excellent communication skills.</li><li>Ability to read, write, and speak the English language is required.</li><li>Bilingual (Spanish) is a plus</li><li>While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear.</li><li>The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl.</li></ul>

Responsibilities: <ul><li>Issue and mail tax invoices to customers, entry tax invoice information in the customers’ system if needed.</li><li>Enter entries in the accounting system.</li><li>Response for organizing and checking the employee reimbursement and payment documents.</li><li>Reconciling the related control accounts.&nbsp;</li><li>Support finishing monthly and yearly closing.</li><li>Support annual/internal audit.</li><li>Assist in organizing financial documents.</li><li>Handle other work or project assigned by manager.</li><li>Maintain and update internal records and reports.</li><li>Provide administrative support to ensure smooth daily operations.</li></ul> Requirement:﻿ <ul><li>Experience: 3+ yrs</li><li>Strong written and spoken English</li><li>Detail-oriented, self-motivated, and able to meet deadlines under pressure</li></ul>

Responsibilities: <ul><li>Issue and mail tax invoices to customers, entry tax invoice information in the customers’ system if needed.</li><li>Enter entries in the accounting system.</li><li>Response for organizing and checking the employee reimbursement and payment documents.</li><li>Reconciling the related control accounts.&nbsp;</li><li>Support finishing monthly and yearly closing.</li><li>Support annual/internal audit.</li><li>Assist in organizing financial documents.</li><li>Handle other work or project assigned by manager.</li><li>Maintain and update internal records and reports.</li><li>Provide administrative support to ensure smooth daily operations.</li></ul> Requirement: <ul><li>Experience: 3+ yrs</li><li>Familiarity with the specific tax regulations in mainland China</li><li>Strong written and spoken English</li><li>Detail-oriented, self-motivated, and able to meet deadlines under pressure</li></ul>

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95 control risk Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

CEO Executive Assistant

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Regional Employee Relations Manager

Regional Sales Manager - North Africa

Quality Senior Lead

Accountant

Accountant

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Skills

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95 control risk Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

CEO Executive Assistant

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Regional Employee Relations Manager

Regional Sales Manager - North Africa

Quality Senior Lead

Accountant

Accountant

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

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TALENT

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