QA QMS officer

Hr Services Chandigarh; Solan; Vor Ort; INR 600.000 - 1.000.000; Vollzeit

Zusammenfassung

Hr Services Chandigarh is seeking a QA/QMS professional to implement and maintain the Quality Management System for OSD and injectable pharmaceutical manufacturing in India.

The role requires 2–5 years of pharma QA/QMS experience, with exposure to EU GMP and WHO-GMP standards, audits, and regulatory inspections. It offers an on-site position and a path to contribute to product quality and compliance.

Strong documentation, CAPA, and data integrity focus with collaboration across functions.

Qualifikationen

• Implement and maintain QMS per EU GMP, WHO-GMP, and applicable regulatory requirements.
• Prepare, review, and control SOPs, protocols, formats, and quality records.
• Handle deviations, CAPA, change control, and investigations.
• Coordinate internal, external, customer, and regulatory audits.
• Manage document control, training records, and data integrity compliance.
• Review non-conformities, OOS/OOT investigations, and corrective actions.
• Support batch record review and product quality investigations.
• Coordinate with QA, QC, Production, Engineering, and Regulatory Affairs.
• Prepare Quality Management Review reports and monitor quality KPIs.
• Ensure compliance with cGMP requirements for OSD and injectable manufacturing.

Aufgaben

• Lead QMS implementation and maintenance across OSD and injectable lines.
• Drive audit readiness and ensure timely closure of CAPA.
• Review batch records and support product quality investigations.
• Collaborate with QA, QC, Production, Engineering, and Regulatory Affairs.

Kenntnisse

QA/QMS

Audit coordination

Documentation control

CAPA & investigations

OOS/OOT investigations

Quality KPIs tracking

Ausbildung

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

Jobbeschreibung

QMS Job Description OSD / Injectable Pharma (5 Years Experience)

• Implement and maintain QMS as per EU GMP, WHO-GMP, and applicable regulatory requirements.
• Prepare, review, and control SOPs, protocols, formats, and quality records.
• Handle deviations, CAPA, change control, and investigations.
• Coordinate internal, external, customer, and regulatory audits.
• Manage document control, training records, and data integrity compliance.
• Review and track non-conformities, OOS/OOT investigations, and corrective actions.
• Support batch record review and product quality investigations.
• Coordinate with QA, QC, Production, Engineering, and Regulatory Affairs.
• Prepare Quality Management Review reports and monitor quality KPIs.
• Ensure compliance with cGMP requirements for OSD (Oral Solid Dosage) and injectable manufacturing.

Qualification: B.Pharm / M.Pharm / M.Sc. or relevant qualification.

Experience: 2- 5 years in pharmaceutical QA/QMS, preferably in OSD and sterile injectable manufacturing.