Responsible for reviewing product development documents and analytical data while ensuring compliance with quality guidelines and regulations. Conduct audits and maintain data integrity in laboratories, support inspection readiness, and participate in continuous improvement activities within QA teams.
ROLE SUMMARY
ROLE RESPONSIBILITIES & SKILL SETS
QUALIFICATIONS
Education:
Relevant experience:
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
- 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
Top Skills
21 Cfr Part 11
Cgmp Requirements
Ich Guidelines
MS Office
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Principal Statistician will design and execute biostatistical components for projects, ensuring compliance with regulatory standards while collaborating with scientists on clinical experiments.
Top Skills:
Computational ToolsData VisualizationGenomic Data Technologies
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Manager, Quality - Business Data Engineer will lead data governance and management, support AI/ML initiatives, and ensure compliance in data solutions while collaborating with various stakeholders.
Top Skills:
Dataiku DssPower BIPythonSnowflakeSpotfireSQL
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Associate will project manage safety aggregate reports for FDA and EMA, coordinating with various teams to ensure timely compliance while documenting and reviewing data accurately.
Top Skills:
Adobe AcrobatBusiness ObjectsIsi ToolboxExcelMicrosoft WordSharepoint
What you need to know about the Pune Tech Scene
Once a far-out concept, AI is now a tangible force reshaping industries and economies worldwide. While its adoption will automate some roles, AI has created more jobs than it has displaced, with an expected 97 million new roles to be created in the coming years. This is especially true in cities like Pune, which is emerging as a hub for companies eager to leverage this technology to develop solutions that simplify and improve lives in sectors such as education, healthcare, finance, e-commerce and more.
