IPQA Officer

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.
• 25 years of experience in QA within a pharmaceutical injectables environment.
• Familiarity with GMP, GDP, and regulatory guidelines (e.g., USFDA, EU, WHO).
• Proficiency in SAP and electronic documentation systems.
• Strong attention to detail, communication, and problem-solving skills.