Manager - QA - QMS

GLOBAL CALCIUM; Krishnagiri; On-site; INR 600,000 - 1,200,000; Full time

Job summary

A pharmaceutical company in Tamil Nadu, India, is seeking an experienced candidate for quality control management. Responsibilities include preparation and review of quality system SOPs, handling internal audits, and ensuring compliance with ISO and regulatory guidelines. The ideal candidate will have a BSc or MSc in Chemistry and 10-16 years of Pharma experience, with skills in analytical method validation and CAPA management.

Qualifications

• 10-16 years of experience in Pharma.
• Expertise in handling OOSs and CAPA.
• Familiarity with ISO and regulatory guidelines.

Responsibilities

• Preparation and review of quality system SOPs.
• Coordination on customer complaints and returns investigation.
• Handling of internal audits and compliance.

Skills

sop

qms

analytical method validation

Education

BSc / MSc Chemistry

Job description

Education

BSc / MSc Chemistry

Years of Experience

10-16 Pharma Experience

Key Responsibilities

• Preparation and review of quality system SOPs as per ISO and regulatory guidelines.
• Receipt, login, review, coordination, follow‑ups with respective departments and tracking of change management with impact assessment and implementation effectiveness.
• Receipt, login, review, coordination, follow‑ups with respective departments and tracking of deviation management, laboratory incidents with implementation of CAPA.
• Handling of OOSs, incidents and OOTs through detailed investigations to establish suitable CAPA.
• Coordination on customer complaints and returns investigation and relevant CAPA.
• Handling of internal audits and compliance as per ICH Q7 guidelines.
• Preparation and review of annual product quality review.
• Co‑ordination in CAPA.
• Ensuring good laboratory practice in the quality control department.
• Review of audit trial records and analytical records.
• Review of instrument calibration and equipment qualification documents related to QC.
• Review of analytical method validation and verification documents.
• Review of method edit forms and stability protocols.
• Review of all logbooks and working standards.
• Review of quality backup and restoration data.
• Handling of reserve sample room.
• Verification of samples (raw material, in‑process/intermediates and finished products).
• Ensure analyst qualification.
• Handling of deviation, change control, OOT, OOS, laboratory incidents, investigations and annual trends.
• Review of instrument and equipment preventive maintenance.
• Review and ensure temperature and humidity monitoring and recording of laboratory area as per requirement.
• Co‑ordination on audit related activities and relevant documents.
• Responsible for verification of data with principles of ALCOA++ as data integrity officer in analytical associated activities.

Skills

Skills: sop, qms, analytical method validation