Pfizer is hiring an Associate Manager – QA Review (CQ) for its Quality Assurance and Control team in Vizag, Andhra Pradesh. This is a full-time, on-premise opportunity for experienced professionals with a strong background in analytical method validation, analytical method transfer, quality review, GMP compliance, and quality control laboratory operations.
Job Overview
| Job Details | Information |
|---|---|
| Company | Pfizer |
| Job Title | Associate Manager – QA Review (CQ) |
| Job Function | Quality Assurance and Control |
| Location | Vizag, Andhra Pradesh, India |
| Job Type | Full-Time |
| Work Location | On-Premise |
| Experience | 8–10 Years |
| Education | Master’s Degree in Chemistry or Pharmacy |
| Job ID | 4960387 |
Eligibility Criteria
Candidates should have a Master’s degree in Chemistry or Pharmacy along with 8–10 years of relevant experience in:
- Analytical Method Transfer
- Analytical Method Validation
- Analytical Method Verification
- Quality Control Laboratory operations
- Quality Review in a sterile dosage manufacturing facility
- Pharmaceutical quality and GMP compliance
Key Responsibilities and Technical Requirements
The selected candidate will be expected to have strong knowledge and practical experience in analytical and quality control activities, including:
Analytical Method Validation and Transfer
- Analytical method validation, transfer and verification.
- Execution of analytical testing using validated procedures.
- Review of analytical method verification and method transfer activities.
- Understanding and application of ICH Q2 (R1/R2), USP and EP requirements.
- Assessment of compendial methods for New Product Introduction (NPI).
- Evaluation of analytical data against established procedure requirements.
Laboratory Instrumentation
Experience with laboratory analytical techniques and equipment such as:
- HPLC with Empower
- GC
- IC
- ICP-MS
- Potentiometry
- UV-Vis
- FTIR
- Karl Fischer
- AAS
- XRF
- NIR
- pH meters
Quality and Regulatory Compliance
Candidates should have knowledge of:
- Change management and change control assessment
- Quality risk management
- ICH Q9 principles
- Regulatory requirements and compendial changes
- Stability management
- GMP compliance
- Regulatory agency inspections
- Data integrity requirements
- Investigation and problem-solving tools
Validation Knowledge
Knowledge of validation principles and practices related to the following areas is required:
- Process Validation
- Cleaning Validation
- Analytical Method Validation
- Water System Qualification
- HVAC System Qualification
- Equipment Qualification
- Utility Qualification
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Additional Technical Knowledge
The role also requires knowledge of the assessment and regulatory requirements associated with:
- Elemental impurities
- Nitrosamine impurities
- Extractables and leachables
- Identification, assay and purity testing
- Related analytical tests
- Compendial requirements under USP, EP, BP and JP
Quality Risk Management
The candidate should have knowledge of ICH Q9 Quality Risk Management and be able to apply risk-based principles for:
- Identifying quality risks
- Assessing risks
- Controlling risks
- Communicating quality risks
- Reviewing risks throughout the product lifecycle
Documentation and Technical Writing
Strong documentation skills are required. The candidate should be capable of preparing technical documents that are:
- Accurate
- Complete
- Clear and unambiguous
- Concise
- Understandable across different organizational levels
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Behavioral and Managerial Skills
Pfizer is looking for candidates with strong:
- Interpersonal and communication skills
- Stakeholder management skills
- Time management skills
- Decision-making abilities
- Problem-solving capabilities
- Scientific and analytical thinking
- Investigation skills
- Cross-functional collaboration
- Leadership and mentoring abilities
- Attention to detail
- Self-accountability and proactive approach
A strong regulatory, GMP compliance and data integrity mindset is also expected.
How to Apply for Pfizer Associate Manager – QA Review Job
Eligible candidates can apply online through the official Pfizer Careers portal.
Company: Pfizer
Position: Associate Manager – QA Review (CQ)
Job ID: 4960387
Location: Vizag, Andhra Pradesh
Important Note
This position is an on-premise, full-time role based in Vizag. Candidates should carefully review the eligibility criteria and job requirements before applying.
Pfizer is an equal opportunity employer and complies with applicable equal employment opportunity legislation in each jurisdiction where it operates.
