Senior Executive

Enzene Biosciences Ltd; Maharashtra; On-site; INR 600,000 - 900,000; Full time

Job summary

Enzene Biosciences Ltd in Maharashtra, India seeks a Senior Executive in IPQA to independently prepare and maintain APQR/PQR for commercial products, and develop a comprehensive PQR roadmap, tracker, and annual schedule.

You will collect and analyse data from Manufacturing, QC, QA, Engineering, Warehouse and RA, ensure timely completion of PQRs, perform data trending, suggest CAPAs, and support CPV, Process Validation, inspections and audits.

Qualifications

• Strong knowledge of PQR/APQR requirements.
• Data trending and analysis skills.
• Proficient in MS Excel and PowerPoint for data presentation.

Responsibilities

• Independently prepare and maintain APQR/PQR for commercial products.
• Develop and maintain a PQR roadmap, tracker, and annual schedule.
• Collect, compile, review, and analyse data from Manufacturing, QC, QA, Engineering, Warehouse, and RA.
• Ensure timely completion and approval of PQRs as per regulatory commitments.
• Data Trending & Analysis.
• Recommend CAPAs and continuous improvement opportunities based on PQR outcomes.
• Support CPV and Process Validation activities.
• Support regulatory inspections and customer audits.
• Present PQR data and quality trends during audits.

Skills

PQR/APQR knowledge

Statistical data analysis

MS Excel (advanced)

PowerPoint

Graphical data presentation

Technical writing

Cross-functional coordination

Education

MSc

M Pharma

M Tech

Job description

• Independently prepare and maintain Annual Product Quality Reviews (APQR/PQR) for commercial products.
• Develop and maintain a comprehensive PQR roadmap, tracker, and annual schedule.
• Collect, compile, review, and analyse data from Manufacturing, QC, QA, Engineering, Warehouse, and RA functions.
• Ensure timely completion and approval of PQRs as per regulatory commitments.
• Data Trending & Analysis.
• Recommend CAPAs and continuous improvement opportunities based on PQR outcomes.
• Support Continued Process Verification (CPV) and Process Validation activities.
• Support regulatory inspections and customer audits.
• Present PQR data and quality trends during audits.

Company Name: Enzene Biosciences Ltd

Designation: Senior Executive

Department: IPQA

PQR & CPV SME for DS/DP

Responsibilities:

• Independently prepare and maintain Annual Product Quality Reviews (APQR/PQR) for commercial products.
• Develop and maintain a comprehensive PQR roadmap, tracker, and annual schedule.
• Collect, compile, review, and analyse data from Manufacturing, QC, QA, Engineering, Warehouse, and RA functions.
• Ensure timely completion and approval of PQRs as per regulatory commitments.
• Data Trending & Analysis.
• Recommend CAPAs and continuous improvement opportunities based on PQR outcomes.
• Support Continued Process Verification (CPV) and Process Validation activities.
• Support regulatory inspections and customer audits.
• Present PQR data and quality trends during audits.

Skills:

• Strong knowledge of PQR/APQR requirements.
• Statistical data analysis and trend evaluation.
• Excellent computer skills, including:
• MS Excel (advanced)
• PowerPoint
• Graphical data presentation.
• Strong technical writing and report preparation skills.
• Effective communication and cross-functional coordination skills.

Education:

MSc, M Pharma, M Tech in related field