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The Role
The Associate Manager in Quality Assurance will ensure compliance with specifications, manage NPI projects, and oversee quality documentation to meet regulatory standards.
Summary Generated by Built In
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
In this role, you will:
- Evaluate and review commercial drug batches to ensure compliance with established specifications.
- Ensuring Zero Defect Technology transfer for new product transfers into site.
- Quality Support and review of Scale-up, pilot bio batches and exhibit beaches to meet regulatory expectations.
- Reviews of Process validation protocols and reports to meet regulatory expectations.
- Review of Optimization Report /Technology Transfer Report, Analytical Data Sheet and Stability Data.
- Responsible to manage New Product Introduction (NPI) projects.
- Review and approval of Project validation protocols, QRM's, Cleaning validation protocols and reports, process validation protocols & reports, Filter validation protocols & reports.
- Review of Analytical Method Transfer and method validation Reports and ensuring the key changes mentioned in the other transfer sites.
- Continuous improvement of templates for presentations, timelines, trackers, and other tools,
- Review , approval and ensure the compliance of SOPs related to technology transfer .
- Review and approval of validation protocols , PRQs and PR's to ensure validation life cycle .
- Support production related documents review and approvals
- Approve investigations and change control activities to maintain compliance with configuration management policies.
- 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)
- Qualification : B.Pharm /M. Pharm/M.Sc
- Experience : 6 to 7 years of experience in sterile injectable technology transfers/ quality Assurance /validations.
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
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Skills Required
- B.Pharm / M. Pharm / M.Sc
- 6 to 7 years of experience in sterile injectable technology transfers/ quality Assurance / validations
- 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
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Health coverage includes comprehensive medical with robust mental‑health networks, plus dental and vision options, and coverage for infertility/family‑building and transgender‑affirming care. Recent U.S. summaries name mental‑health partners and outline multiple plan choices.
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Retirement Support — The retirement program provides a 401(k) with company match plus an additional employer Retirement Savings Contribution, along with financial‑planning support and company‑paid life and disability insurance. These elements are highlighted as part of the core U.S. package.
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Parental & Family Support — Parental leave is described as up to 26 weeks in the U.S. when combining paid non‑medical parental leave with medical recovery where applicable, with exact pay and weeks dependent on circumstances and plan elections. Family‑building support includes egg preservation, adoption, and surrogacy coverage.
Pfizer Insights
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
Not Specified
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