Officer - QA ( IPQA profile)

GUFIC BIOSCIENCES LIMITED; Pithampur; On-site; INR 700,000 - 1,100,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED is seeking a qualified QA professional to support IPQA, line clearance and BMR/BPR reviews in its sterile injectables manufacturing facility. The role emphasizes GMP/GDP compliance, traceability in SAP, and strong analytical documentation.

You will assist in OOS/OOT investigations and CAPA implementations, ensuring aseptic practices and environmental monitoring in sterile areas, with exposure to regulatory audits and product quality assurance.

Qualifications

• Bachelor's or Master's in Pharmacy required.
• Knowledge of GMP/GDP and regulatory guidelines (USFDA, EU, WHO) preferred.
• Strong attention to detail, communication, and problem-solving skills.

Responsibilities

• Monitor and ensure IPQA compliance during manufacturing and packing.
• Perform and document line clearance before batch initiation and product changes.
• Review BMR/BPR for completeness, accuracy and compliance; coordinate with production.
• Support analytical documentation and assist in OOS/OOT investigations.
• Manage quality entries and batch releases in SAP; ensure traceability for audits.
• Ensure aseptic practices and environmental monitoring in sterile areas.

Skills

IPQA knowledge

Line clearance experience

BMR/BPR review

Analytical QA

SAP documentation

Injectables manufacturing

Education

Bachelor's/Master's in Pharmacy

Tools

SAP

Job description

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).
• Strong attention to detail, communication, and problem-solving skills.