Job Opening – QA Executive (IPQA / Documentation)
Saga Lifesciences Ltd.
OSD Pharmaceutical Manufacturing Plant
Chacharwadi Vasna, Sanand, Ahmedabad, Gujarat – 382210
About the Company:
Saga Lifesciences Pvt. Ltd., established in 1981, is a reputed pharmaceutical company with a strong global presence. Within a decade of inception, the company entered the international market and currently exports its products to over 40 countries worldwide. We are committed to quality manufacturing and regulatory compliance.
Roles & Responsibilities –
- Review of BMR, BPR & MER documents.
- Review of Process Validation, Cleaning Validation, Hold Time Study Protocols, and Stability Study Protocols.
- Review of executed BMR/BPR, Process Validation, Cleaning Validation, and Equipment Qualification documents.
- Review and approval of artwork materials.
- Monitoring and ensuring compliance with cGMP, GDP, SOPs, and regulatory requirements.
- Coordination with Production, QC, and other cross-functional departments for QA compliance activities.
- Handling documentation review and archival activities.
- Support during internal audits and regulatory inspections.
- Ensuring data integrity compliance across QA systems.
Eligibility Criteria -
- Education: B.Pharm & M.Pharm (Pharmaceutics preferred)/ B.Sc / M.Sc
Experience Required -
Required Skills -
- Strong knowledge of OSD pharmaceutical manufacturing processes.
- Hands-on experience in QA documentation and IPQA activities.
- Good understanding of Process Validation, Cleaning Validation, Qualification, and Stability Studies.
- Knowledge of regulatory guidelines and pharmaceutical documentation practices.
- Good communication and interpersonal skills.
Preferred Candidate Profile -
- Apply only if having relevant experience in OSD Pharmaceutical Manufacturing.
- Immediate joiners will be preferred.
Pay: ₹320,129.65 - ₹550,228.78 per year
Benefits:
- Health insurance
- Leave encashment
- Provident Fund
Application Question(s):
- How many years of _____ experience do you having in Reviewing draft BMR, BPR and MFR?
Education:
Experience:
- OSD Plant: 3 years (Required)
Location:
- Ahmedabad, Gujarat (Preferred)
Work Location: In person
