Associate Manager - Quality Assurance
- Pfizer
- 6 - 10 years
- Visakhapatnam
- 8 hours ago
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Job Description
Use Your Power for Purpose
Every day, Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
- Ensure all aspects of the change control process are followed, including management of change proposals, evaluations, approvals, implementations, and effectiveness checks.
- Review and approved risk assessments to evaluate the potential impact of changes on product quality and compliance. Ensure changes comply with industry regulations and internal quality standards.
- Coordinate with cross-functional teams to manage change requests and approvals.
- Communicate changes to relevant stakeholders, including regulatory affairs, quality assurance, and production teams.
- Review of Technology Transfer Documents, Scale Up protocols , Reports, Exhibit batch documents and process validation documents .
- Ensuring the Technology Transfer of injectables
- Quality Risk Assessment document review and approvals
- Strong knowledge on validation life cycle, validation concepts and review and approval of FAT,SAT, URS, Equipment Qualification Protocols IQ/OQ/PQ, PRQ documents of injectable fill finish line
- Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
- Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
- Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Here Is What You Need (Minimum Requirements)
- M.Pharm/B.Pharm/MSc with 8+ years of experience injectable manufacturing , Quality Assurance .
- Required to work in three shifts Operations (A/B/C)
- Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
- Strong critical thinking skills
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
- Proactive approach to problem-solving
Bonus Points If You Have (Preferred Requirements)
- Experience in quality administered systems
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
- Ability to mentor and review the work of other colleagues
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: Manufacturing quality assurance Sterile Technology Transfer Floor & chain management
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