Qa Executive

Utkarsh Placement Pvt. Ltd.; Mohali; On-site; INR 420,000 - 540,000; Full time

Job summary

Utkarsh Placement Pvt. Ltd. in Dera Bassi, Punjab, invites applications for a QA Executive / QA Officer / Sr. QA Officer with 3–5 years of API QA experience. The role emphasizes cGMP documentation, batch-record review and investigations across QA systems.

You will coordinate with Production, QC and Engineering, ensure data integrity, and support audits and training to maintain quality commitments in a pharmaceutical API manufacturing setting.

Qualifications

• 3–5 years of QA experience in an API manufacturing facility.
• Strong knowledge of cGMP documentation and pharmaceutical quality systems.
• Hands-on experience with deviations, CAPA, change controls and investigations.
• Familiarity with regulatory standards such as WHO‑GMP, ICH, USFDA or EU‑GMP.
• Good documentation, communication and cross‑functional coordination skills.

Responsibilities

• Prepare, review, revise and control QA documents per cGMP and regulatory requirements.
• Review BMR, BPR, logbooks and analytical documentation.
• Handle deviations, incidents, CAPA, change controls and root‑cause investigations.
• Prepare and revise SOPs, formats, protocols and quality‑system documents.
• Manage document issuance, retrieval, archival, version control and record retention.
• Conduct shop‑floor monitoring, line clearance and in‑process compliance checks.
• Support equipment qualification, process validation and cleaning‑validation activities.
• Review calibration, preventive‑maintenance and qualification records.
• Ensure compliance with data‑integrity requirements and ALCOA+ principles.
• Participate in internal, customer and regulatory audits and support closure of audit observations.
• Coordinate with Production, QC, Warehouse and Engineering departments on quality‑related matters.
• Conduct or coordinate cGMP and SOP training and maintain training records.
• Ensure timely completion and closure of all assigned quality‑system activities.

Skills

QA experience

cGMP documentation

CAPA investigations

Regulatory standards

Cross-functional coordination

Education

B.Pharm / M.Pharm / B.Sc. / M.Sc.

Job description

Job Description QA Executive / QA Officer/ Sr. QA Officer

Location: Dera Bassi, Punjab
Department: Quality Assurance
Industry: Pharmaceutical API Manufacturing
Experience: 3–5 years in API Quality Assurance
Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc.

Key Responsibilities

• Prepare, review, revise and control QA documents as per cGMP and regulatory requirements.
• Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), logbooks and analytical documentation.
• Handle deviations, incidents, CAPA, change controls and root‑cause investigations.
• Prepare and revise SOPs, formats, protocols and other quality‑system documents.
• Manage document issuance, retrieval, archival, version control and record retention.
• Conduct shop‑floor monitoring, line clearance and in‑process compliance checks.
• Support equipment qualification, process validation and cleaning‑validation activities.
• Review calibration, preventive‑maintenance and qualification records.
• Ensure compliance with data‑integrity requirements and ALCOA+ principles.
• Participate in internal, customer and regulatory audits and support closure of audit observations.
• Coordinate with Production, QC, Warehouse and Engineering departments on quality‑related matters.
• Conduct or coordinate cGMP and SOP training and maintain training records.
• Ensure timely completion and closure of all assigned quality‑system activities.

Candidate Profile

• Must have 3–5 years of QA experience in an API manufacturing facility.
• Strong knowledge of cGMP documentation and pharmaceutical quality systems.
• Hands‑on experience with deviations, CAPA, change controls, investigations and batch‑record review.
• Familiarity with regulatory standards such as WHO‑GMP, ICH, USFDA or EU‑GMP.
• Good documentation, communication and cross‑functional coordination skills.