Associate Manager Quality Assurance
7 days ago
ROLE SUMMARY Responsible for reviewing documents related to product development analytical data including electronic data chromatographic data and audit trails as well as instrument and equipment qualification Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic records Conduct periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirements Liaise effectively with global BL and OQ colleagues to achieve organizational objectives Maintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility BET CCIT and associated development requirements Possess in-depth knowledge regarding sterility requirements and filter validation activities in accordance with PDA technical reports Demonstrate familiarity with requirements for sterile ANDA product development and combination products Exhibit strong proficiency in MS Office applications including Excel Word and PowerPoint presentation preparation ROLE RESPONSIBILITIES SKILL SETS Awareness of DI and ALOCA principles Basic understanding of cGMP requirements including 21 CFR part 210 and 211 ICH guidelines and sterile product requirements Maintain compliance in laboratories and during document review Ability to perform statistical evaluation and analysis of analytical data during method development and validation review Effective communication skills Adherence to discipline and self-motivation Participate in the implementation of new initiatives and goals within the QA function and with business line partners to support consistency efficiency and compliance Manage time to meet agreed targets and plan work activities for projects within assigned teams Suggest improvements and participate in continuous improvement activities Contribute to the development and compliance of quality and business line partner procedures Provide support for inspection readiness efforts internal audits and regulatory inspections as required QUALIFICATIONS Education Master of science in chemistry Master of pharmacy Relevant experience Relevant work experience in an analytical data review and Technology transfer and cGMP pharmaceutical sterile manufacturing area Location On premise Work Location Assignment On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates Quality Assurance and Control
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Quality Assurance Associate
4 days ago
Coimbatore, Tamil Nadu, India Avantor Full time**The**Opportunity**: Avantor is looking for an Associate for the Quality Assurance NA team. It is an intermediate-level position. The associate is responsible for preparing customer files, review batch records, and release batch records. Liaison to our customers' quality assurance groups for batch record review and release. Manage the communication between...
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Quality Assurance Manager
1 week ago
Chennai, Tamil Nadu, India P S Quality Certification Full timeRole & responsibilities:1.Good Exposure in ISO/IATF Documentation2.Able to implement the Standard requirements in Shop floor/Projects3.Able to handle team of Quality engineers4.Good exposure in conducting Internal Audit,MRM.5.Handling Customer complaints and closing with proper action plans.6.Handling Certification body audit & Customer Audit7.Responsible...
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Quality Assurance Associate
2 days ago
Chennai, Tamil Nadu, India Unilink Pharma Pvt. Ltd. Full timeWorking knowledge of tools, methods and concepts of quality assurance Solid knowledge of relevant regulatory standards Good communication skills, both verbal and written Excellent data collection and analysis skills Strong attention to detail **Job Types**: Full-time, Permanent, Fresher Pay: ₹16,875.00 - ₹27,895.00 per month **Benefits**: - Provident...
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Quality Assurance
1 week ago
Chennai, Tamil Nadu, India BNR Infrastructure Projects Private Limited Full time**Job Summary** We are seeking a detail-oriented and experienced **Quality Assurance Engineer** to ensure the quality of civil construction works across all project phases. The QA Engineer will develop and implement quality assurance protocols, inspect construction processes and materials, and ensure compliance with project specifications, codes, and safety...
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Senior Quality Assurance Manager
5 days ago
tamil nadu, India beBeeQuality Full timeJob Title: Senior Quality Assurance ManagerJob OverviewWe are seeking an experienced Senior Quality Assurance Manager to lead our QA team and ensure the highest quality of our software products. This role involves overseeing the development and implementation of quality assurance processes, strategies, and best practices.The ideal candidate will have a...
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Quality Assurance
6 hours ago
Adyar, Chennai, Tamil Nadu, India Unidos Technology Full timeWe are looking for Quality Assurance in Healthcare Department, About us: Shield is founded in 1995. One of the respected Pharma companies in India under Gynecology segment. Shield portfolio offers a wide range of brands supported by scientific findings from clinical trials and research studies. We are in the field of Women’s Healthcare. About the...
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Associate, Quality Services
1 week ago
Chennai, Tamil Nadu, India ADCI MAA 12 SEZ Full time**DESCRIPTION**: An Associate, Quality Services owns manual execution of documented set of task instructions for a list of components or features of a product, as per the defined productivity and quality targets, agreed SLA and adhere to processes. Key job responsibilities Roles & Responsibilities: - Execute test instructions and report test results...
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Quality Assurance
7 days ago
Coimbatore, Tamil Nadu, India VILVAH STORE Full timeCompany OverviewVilvah Store Private Limited is a pioneering sustainable skincare brand located in Coimbatore specializing in high-performance formulations made with the freshest and purest ingredients Our commitment to using pure agricultural produce essential oils and other natural components without harsh additives reflects in the quality of our offerings...
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Associate Manager Quality Assurance
2 weeks ago
Chennai, India Pfizer Full timeROLE SUMMARY Responsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualification Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic records Conduct...
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Specialist, Quality Assurance Engineering
4 weeks ago
Chennai, Tamil Nadu, India Fiserv Full timeCalling all innovators - find your future at Fiserv We re Fiserv a global leader in Fintech and payments and we move money and information in a way that moves the world We connect financial institutions corporations merchants and consumers to one another millions of times a day - quickly reliably and securely Any time you swipe your credit card pay through a...