Senior Executive - QA - IPQA(DS)

Enzene Biosciences Ltd; Maharashtra; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Enzene Biosciences Ltd in Maharashtra is seeking a Senior Executive QA to ensure cGMP compliance on the manufacturing floor for Drug Substance. Candidates should have 6-9 years of hands-on experience in QA activities, particularly with knowledge of regulatory guidelines.

The role includes responsibilities such as conducting GMP rounds, reviewing batch records, and managing quality systems. The position requires excellent communication and analytical skills to work effectively with cross-functional teams.

Qualifications

• 6 to 9 years of experience in QA or relevant field.
• Hands-on experience with DS/DP shop floor QA activities.

Responsabilités

• Perform manufacturing line clearance for DS activities.
• Ensure compliance of in-process checks during manufacturing operations.
• Conduct routine GMP rounds at the Drug Substance facility.
• Review batch manufacturing records for accuracy.
• Manage Standard Operating Procedures related to shop floor.
• Initiate and manage Change Control and CAPA.

Connaissances

cGMP knowledge

Quality Management Systems (QMS)

Documentation control

Analytical skills

Problem-solving skills

Effective communication

Formation

M.Sc / M.Pharm

Description du poste

Job Purpose: To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.

Job Title: Senior Executive QA (DSQA)

Department: Quality Assurance

Experience: 6 to 9 Years

Qualification: M.Sc / M.Pharm

Key Responsibilities

• Perform manufacturing line clearance on the shop floor for DS activities.
• Ensure proper execution and compliance of in-process checks during manufacturing operations.
• Conduct routine GMP rounds at the Drug Substance facility and document observations.
• Review online batch manufacturing records (BMR) for accuracy, completeness, and compliance.
• Review and approve process validation protocols and reports, cleaning validation protocols and reports.
• Review and manage Standard Operating Procedures (SOPs) and other protocols/reports related to shop floor operations.
• Coordinate collection and submission of samples as per BMR, specifications, process validation, and stability protocols.
• Perform regular shop floor compliance rounds to ensure adherence to cGMP and follow up on corrective actions.
• Prepare and support Annual Product Quality Review (APQR/PQR) documents.
• Initiate and manage Change Control, Deviations, Incidents, and CAPA, including investigation support and timely closure.
• Participate in QMS investigations and root cause analysis.
• Ensure continuous cGMP compliance and regulatory readiness at the shop floor.
• Perform risk assessments for critical manufacturing and quality processes.

Skills & Competencies

• Strong knowledge of cGMP, QMS, and regulatory requirements.
• Hands‑on experience with DS/DP shop floor QA activities.
• Understanding of process validation, cleaning validation, and in-process controls.
• Experience in BMR review and documentation control.
• Good analytical, investigation, and problem‑solving skills.
• Effective communication and coordination with cross‑functional teams.

Regulatory Exposure

• USFDA, EMA, WHO, and other global regulatory guidelines (preferred).