Research Associate – II Nitrosamines

Manager – R&D F&D Emulsions

Reference Standard Coordinator

Senior Consultant – Commercial Solutions

Finance Manager

Quality Senior Lead

Desktop Support Engineer

Accountant

Manufacturing Engineer

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>

Job Description: <ul><li>The role of a Manager – R&amp;D (Research &amp; Development) F&amp;D (Food &amp; Drink) Emulsions typically involves overseeing the research, development, and innovation of emulsions used in the food and beverage industry.&nbsp;</li><li>The manager leads the R&amp;D team to develop new emulsion-based products or improve existing ones to meet customer requirements, industry standards, and market demands.</li></ul> Responsibilities: Planning of Project technical feasibility experiment: <ul><li>End to end planning for Resource availability on time Planning of developmental trials, PDR studies/QBD additional studies for ANDA products</li><li>Planning of developmental trials, PDR studies/QBD additional studies for ANDA products.</li><li>Monitoring of development trials.</li><li>Compilation of the development data.</li><li>Ensuring development as per QBD approach</li><li>Review the technical documents e.g. DMBD, PDR and other protocols &amp; reports.</li><li>Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time project execution.</li><li>Technology transfer of Drug product [ANDA, 505 (b)(2), Complex injectables]</li><li>Exhibit batch execution [ANDA, 505 (b)(2), Complex injectables]</li><li>Support for Process validation and commercial batches [ANDA, 505 (b)(2), Complex injectables]</li><li>Technology transfer documents review Products developed by CRO as per regulatory requirement.</li><li>Support &amp; coordination with CMOs for successful technology transfer</li><li>Fulfilling the regulatory requirements by designing the trials</li><li>Training &amp; knowledge enhancement of the team</li><li>Design &amp; Authorization of SOPs</li><li>Execution &amp; approval process of New Equipments/Instruments for projects in upcoming portfolio &amp; continuous improvement of Development Lab.</li><li>Adoption of GQP (Procedures integration with systems)</li></ul> Requirements: <ul><li>3–4 years of team handling experience</li><li>3–4 years of hands-on work in emulsions (oil-based and water-based)</li><li>Full product lifecycle exposure: development → scale-up → filing</li><li>Minimum 5–10 regulatory filings (e.g., ANDA, NDA)</li><li>Strong people management and leadership capabilities</li><li>Preferred experience in ophthalmic formulations</li><li>Background in injectable manufacturing environment is an added plus</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>

The RoleTo provide expertise, advice, support, report on, and lead large scale/complex supply chain solution projects that optimises organisational value chain integration and performance, underpinned by supply chain and logistics capabilities. The Senior Consultant is experienced in leading cross-functional teams, conducting analysis, providing recommendations and guidance towards the delivery of strategic multiple large-scale supply chain solutions projects. Expected to work closely with clients to understand their business needs, identify opportunities for improvement and design solutions to optimise their supply chains. Manages and balance the requirements between business objectives and project requirements.&nbsp;Recognise trends, patterns, or themes in complex data, and leverages experience to solve complex problems.&nbsp;Understands the importance of project governance, stakeholder management, commercial models, and managing project teams. Key Responsibilities·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Grow clients and revenue.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Overseer quality of analysis and solution teams outputs ·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Design the test methodology and success criteria for value-chain improvement solutions across multiple capabilities and regions.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Facilitate cross functional business improvement and solutions development workshops.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Obtain and document client requirements to enable design of integrated fit-for-purpose business solutions that improve client’s value chain.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Support management of prospective client pipeline by evaluating and qualifying solution leads·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Project team performance management Minimum RequirementsQualifications required&nbsp;<ul><li>B.Eng Industrial or BCom Logistics (Honours) or BCom Supply Chain Management (Honours) [NQF level 7 or higher]&nbsp;</li></ul>Skills and experience required<ul><li class="ql-align-justify">8 - 12 years relevant work experience (operations and/or solution design role)</li><li class="ql-indent-1 ql-align-justify">Applies supply chain management knowledge, solves problems in the supply chain using this knowledge.</li><li class="ql-align-justify">Proven track record of leadership and managing project teams</li><li class="ql-indent-1 ql-align-justify">The ability to inspire, motivate and direct individuals to take ownership of-, and achieve desired outputs.</li><li class="ql-indent-1 ql-align-justify">Establishes an atmosphere of trust and mutual respect between team members. </li><li class="ql-indent-1 ql-align-justify">Clearly articulates a goal and purpose to ensure alignment of team members towards a desired objective.</li><li class="ql-indent-1 ql-align-justify">Manages performance of team members.&nbsp;&nbsp;</li><li class="ql-indent-1 ql-align-justify">Provides performance feedback to team members in a constructive manner</li><li class="ql-align-justify">Proven track record of delivering successful projects</li><li class="ql-indent-1 ql-align-justify">The ability to ensure high standards of accuracy, quality, and service delivery to meet and exceed client expectations.</li><li class="ql-indent-1 ql-align-justify">Applies knowledge, tools, and technical expertise to support value creation, tailoring it to the specific needs of the client.</li><li class="ql-align-justify">Thorough understanding of capabilities offered by our client.</li><li class="ql-align-justify">Understanding of financial and management accounting (commercial models).</li><li class="ql-align-justify">Demonstrated understanding of supply chain costs, cost drivers and cost efficiencies levers.</li><li class="ql-align-justify">Ability to review business analysis process and deliverables in order to recommend improvements.</li><li class="ql-align-justify">Exceptional analytical skills.</li><li class="ql-align-justify">Creating &amp; delivering professional presentations.</li><li class="ql-align-justify">Written and verbal communication, including technical writing skills.</li><li class="ql-align-justify">Time management: comfortable working under pressure with stringent deadlines and complex deliverables. Flexible hours to achieve deliverables (sometimes required to work in addition to/outside of normal business hours).</li><li class="ql-align-justify">Plan, manage and account for own time according to tasks’ priorities with a high attention to detail.</li><li class="ql-align-justify">Self-motivated and proactive.</li><li class="ql-align-justify">Able to think logical and objectively with the ability to be innovative in approach and solution design / problem solving.</li><li class="ql-align-justify">Willingness to travel (predominantly Africa, ad-hoc).</li></ul>

Requirements Financial Management &amp; Reporting: <ul><li class="ql-align-justify">Oversee all accounting operations of the site including Accounts Payable, Accounts Receivable, General Ledger, Cost Accounting, and Inventory Accounting.</li><li class="ql-align-justify">Ensure timely and accurate preparation of financial statements in accordance with local Polish GAAP and Group IFRS standards.</li><li class="ql-align-justify">Manage the period-end closing process effectively and efficiently.</li><li class="ql-align-justify">Prepare comprehensive financial reports, including monthly variance analysis, for local management and global stakeholders.</li><li class="ql-align-justify">Responsible for cash flow management, forecasting, and optimization at the site level, coordinating closely with the Global Treasury Director.</li><li class="ql-align-justify">Lead the annual budgeting and forecasting processes for the Polish site, in conjunction with the Global FP&amp;A Director.</li><li class="ql-align-justify">Monitor and analyze key financial performance indicators (KPIs) and provide actionable insights to improve profitability and efficiency.</li><li class="ql-align-justify">Assessments of CapEx proposals by site.</li></ul> Business Partnering &amp; Strategy: <ul><li class="ql-align-justify">Act as a key strategic partner to the General Manager, Poland, providing financial guidance and support for operational decisions.</li><li class="ql-align-justify">Participate actively in local management team meetings, contributing to overall business strategy and operational improvements.</li><li class="ql-align-justify">Identify opportunities for cost reduction, revenue enhancement, and process optimization.</li><li class="ql-align-justify">Conduct financial analysis for new projects, investments, and business initiatives.</li><li class="ql-align-justify">Collaborate with sales, operations, and other departments to ensure financial targets are met.</li></ul> Controllership &amp; Compliance: <ul><li class="ql-align-justify">Ensure robust internal controls are in place and adhered to, safeguarding company assets.</li><li class="ql-align-justify">Manage statutory audits and ensure compliance with all Polish financial regulations and tax laws (with external support for complex tax matters).</li><li class="ql-align-justify">Responsible for timely and accurate submission of all local tax declarations (VAT, CIT, etc.), coordinating with external tax advisors as needed.</li><li class="ql-align-justify">Oversee compliance with global financial policies and procedures.</li><li class="ql-align-justify">Manage relationships with external auditors, banks (for local operational needs), and other financial service providers.</li></ul> Team Leadership &amp; Development: <ul><li class="ql-align-justify">Lead a team of 4 Accountants and 2 Controllers, fostering a culture of continuous improvement and high performance.</li><li class="ql-align-justify">Set clear objectives, provide regular feedback, and conduct performance reviews for the finance team.</li><li class="ql-align-justify">Foster strong collaboration within the finance team and with other departments.</li></ul> Global Collaboration: <ul><li class="ql-align-justify">Work closely with the Global FP&amp;A Director on budgeting, forecasting, and performance analysis.</li><li class="ql-align-justify">Collaborate with the Global Treasury Director on cash management strategies and funding requirements.</li><li class="ql-align-justify">Provide timely and accurate financial information to the Global CFO and other global finance leaders.</li><li class="ql-align-justify">Ensure alignment of local financial practices with global standards and systems.</li></ul> Requirements: <ul><li>Education: Bachelors degree in Finance, Accounting, Economics, or a related field. Masters degree is preferred.</li></ul> Experience: <ul><li>Minimum of 8-10 years of progressive experience in finance roles, with at least 3-5 years in manufacturing environment.</li><li>Proven experience working in an international or multinational company is essential.</li><li>Strong understanding of Polish GAAP and IFRS.</li><li>Demonstrated experience with ERP systems (e.g., SAP, Oracle).</li><li>Experience managing and developing a finance team.</li></ul> Skills: <ul><li>Fluent in Polish and English (both written and spoken).</li><li>Excellent analytical and problem-solving skills, with a strong attention to detail.</li><li>Strong leadership and interpersonal skills, with the ability to influence and collaborate effectively across all levels of the organization.</li><li>Proven ability to work independently and manage multiple priorities in a fast-paced environment.</li><li>Strategic thinking with a hands-on approach.</li><li>Proficient in Microsoft Office Suite, especially Excel.</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>Performed Desktop Support services to users&nbsp;</li><li>This includes receiving, prioritizing, documenting and actively resolving end user help requests and escalating incidents when necessary to maintain customer satisfaction and SLA expectations.</li><li>Perform imaging/re-imaging&nbsp;</li><li>Perform asset inventories</li><li>Perform technical escalation to 3rd party vendor or resolver groups (where appropriate)</li><li>Updates Incident records</li><li>Creates and updates work instructions</li><li>Document standards and procedures </li></ul> Requirements: <ul><li>Min. ITE/Diploma graduate with 1 year experience in desktop support</li><li>Min 1 year experience in Microsoft Windows 10 and Microsoft Office 365</li><li>Clear Spoken &amp; Written English and Chinese.</li></ul> possess at least one (1) of the following certifications or their equivalent:&nbsp;<ul><li>CompTIA A+;</li><li>CompTIA Security+;</li><li>CompTIA Network+;</li><li>Microsoft Certified: Windows Client; and</li><li>Microsoft Certified: Managing Modern Desktops.</li><li>Previous IT helpdesk and/or call centre support experience, including providing remote support via the telephone or using remote tool will be added advantages</li><li>Demonstrate knowledge in the support of workstations, and related components</li><li>Good verbal and written communication skills</li><li>Good coordination skills&nbsp;</li><li>Ability to prioritize effectively and work with a sense of urgency</li><li>Effectively communicates with teammates and managers</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>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

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111 accounting standards Jobs found

Research Associate – II Nitrosamines

Manager – R&D F&D Emulsions

Reference Standard Coordinator

Senior Consultant – Commercial Solutions

Finance Manager

Quality Senior Lead

Desktop Support Engineer

Accountant

Accountant

Manufacturing Engineer

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Skills

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Jobtitle

111 accounting standards Jobs found

Research Associate – II Nitrosamines

Manager – R&D F&D Emulsions

Reference Standard Coordinator

Senior Consultant – Commercial Solutions

Finance Manager

Quality Senior Lead

Desktop Support Engineer

Accountant

Accountant

Manufacturing Engineer

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

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Contact Us

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