Macleods Pharmaceuticals is looking for qualified professionals to join its PDR-DQA Department in Andheri, Mumbai. This opportunity is suitable for M.Pharm Pharmaceutics candidates with 1–3 years of relevant PDR-DQA experience who want to build their careers in pharmaceutical development quality assurance.
The PDR-DQA job in Mumbai involves quality oversight of product development activities, SOP and guideline management, review of Product Development Reports (PDR), laboratory notebooks, Master Manufacturing Formula (MMF), qualification documentation, training records and data archival.
Candidates with hands-on exposure to pharmaceutical development, documentation, laboratory quality systems and cross-functional coordination can apply for this Macleods Pharma PDR-DQA vacancy.
Key Responsibilities
Selected candidates will be responsible for:
- Preparing and reviewing Standard Operating Procedures (SOPs) and departmental guidelines.
- Providing training on approved SOPs and guidelines.
- Maintaining and archiving employee training records.
- Reviewing and approving Product Development Reports (PDR).
- Reviewing Laboratory Notebooks (LNBs) and associated development documentation.
- Conducting laboratory rounds to ensure compliance with applicable quality requirements.
- Verifying that laboratory equipment is within its approved calibration period.
- Checking equipment identification and documentation status.
- Monitoring laboratory environment and cleanliness standards.
- Reviewing Master Manufacturing Formula (MMF) documents.
- Providing quality support for IQ/OQ/PQ documentation related to equipment qualification.
- Archiving PDR data and associated backup files according to established procedures.
- Communicating and coordinating with cross-functional teams involved in pharmaceutical product development.
Qualification & Eligibility
Candidates applying for the Macleods Pharmaceuticals PDR-DQA job should meet the following requirements:
Educational Qualification:
M.Pharm in Pharmaceutics
Experience:
1–3 years of relevant experience in PDR-DQA / Development Quality Assurance.
Candidates should preferably have working knowledge of:
- SOP preparation and review
- Pharmaceutical development documentation
- Product Development Reports
- Laboratory notebooks
- Master Manufacturing Formula
- Equipment calibration and qualification
- IQ/OQ/PQ documentation
- Training documentation
- Data archival
- Pharmaceutical quality systems
- Cross-functional coordination
What Is a PDR-DQA Role?
PDR-DQA (Product Development Research – Development Quality Assurance) supports quality and compliance activities associated with pharmaceutical product development.
Professionals working in PDR-DQA help ensure that development laboratories, documentation, equipment qualification activities, product development records and associated quality processes comply with established procedures and pharmaceutical quality requirements.
This makes the role particularly relevant for M.Pharm Pharmaceutics professionals interested in pharmaceutical R&D quality assurance and development quality systems.
Why Consider This Opportunity?
This role can provide professional exposure to multiple areas of pharmaceutical development quality assurance, including SOP management, PDR review, MMF review, laboratory compliance, equipment qualification documentation and quality-system activities.
It also offers candidates an opportunity to work closely with product development and other cross-functional pharmaceutical teams.
How to Apply
Interested and eligible candidates can share their updated CV at:
Email: vishalb@macleodspharma.com
Candidates should include the following information while applying:
- Total Experience
- Current CTC
- Expected CTC
- Notice Period
- Current Working Location