Key Responsibilities
- In-Process Quality Assurance (IPQA):
- Monitor and ensure compliance during manufacturing and packing operations.
- Conduct routine checks and validations to maintain product quality.
- Line Clearance Activities:
- Perform and document line clearance before batch initiation and between product changes.
- Ensure adherence to GMP and prevent cross-contamination.
- Batch Manufacturing Record (BMR) & Batch Packing Record (BPR) Review:
- Review and verify BMR/BPR for completeness, accuracy, and compliance.
- Identify discrepancies and coordinate with production for resolution.
- Analytical Quality Assurance (AQA):
- Support analytical documentation and ensure lab compliance.
- Assist in OOS/OOT investigations and CAPA implementation.
- SAP Documentation & Transactions:
- Manage quality-related entries and batch release processes in SAP.
- Maintain digital traceability and support audits with SAP data.
- Injectables Manufacturing Oversight:
- Ensure aseptic practices and environmental monitoring in sterile areas.
- Support validation and qualification activities for injectable products.
Qualifications & Skills
- Bachelors/Masters degree in Pharmacy.
- Familiarity with GMP, GDP, and regulatory guidelines (e.g., USFDA, EU, WHO).
- Robust attention to detail, communication, and problem-solving skills.
Interested candidates can mail their resume at
[email protected]
📌 Officer - QA ( IPQA profile) (Indore)
🏢 Gufic Biosciences
📍 Indore