BDR Pharma is seeking a skilled Executive to handle Quality Assurance and Process Validation activities for Oral Solid Dosage (OSD) forms. The ideal candidate will have a strong pharma industry background and expertise in preparing and reviewing validation documentation and protocols.
Key Responsibilities:
- Prepare and review Validation Master Plans (VMP, PVMP, CVMP, QMP) and ensure adherence.
- Develop and review Qualification and Validation documents; execute protocols as per guidelines.
- Prepare and review Continued Process Verification protocols and summary reports.
- Update equipment and utility periodic requalification/re-verification schedules monthly or as required.
- Manage quality documents including BMR, BPR, log books, protocols, reports, and SOPs throughout their lifecycle.
- Prepare and review SOPs related to qualification and validation.
- Prepare and review URS, FS, DS, DQ, RA, IQ, OQ, PQ, and summary reports for equipment, systems, and utilities.
- Prepare and review PPQ and cleaning validation protocols and summary reports.
- Monitor PPQ and cleaning validation activities.
- Coordinate with cross-functional teams for qualification, requalification, and validation activities.
- Address deviations identified during qualification and validation.
- Participate in investigations and support change management, deviations, CAPA, and other quality management systems.
Qualifications:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm).
- 5 to 7 years of experience in pharmaceutical QA and process validation.
- Strong knowledge of validation protocols and quality management systems.
- Experience in Oral Solid Dosage (OSD) manufacturing environment preferred.
About BDR Pharma
BDR Pharma is a reputed pharmaceutical company located in Baska, Halol. Recognized as a Great Place To Work, BDR Pharma is committed to quality, innovation, and employee growth. The company specializes in manufacturing high-quality pharmaceutical products and maintains stringent quality standards to ensure patient safety and regulatory compliance.
How to Apply
Interested candidates who meet the above criteria are encouraged to apply immediately.
- Contact Person: Neha Thakkar
- Phone: 6358139082
- Email: neha.thakkar@bdrpharma.com
