Job Summary

Responsible for managing the Quality Management System (QMS), document control, SOP preparation and revision, CAPA, Change Control, Deviations, customer complaints, batch documentation review, and batch release activities. Ensure compliance with applicable cGMP requirements, ISO 13485:2016, data integrity, and regulatory standards.

Role & responsibilities

- Prepare, review, issue, revise, control, and archive SOPs, formats, and other quality documents.
- Coordinate with various departments for timely review, approval, revision, and implementation of controlled documents.
- Manage document issuance, retrieval, and control in accordance with the Document Control System.
- Initiate, track, review, and close QMS activities, including CAPA, Change Control, Deviations, and Customer Complaints.
- Ensure implementation and maintenance of QMS requirements in accordance with ISO 13485:2016, the Quality Manual, and applicable regulatory requirements.
- Prepare and maintain calibration, qualification, validation, preventive maintenance, and training matrices.
- Control quality documents and records, including BMR, BPR, MFR, specifications, protocols, reports, and logbooks.
- Manage control samples, including receipt, storage, reconciliation, and periodic inspection.
- Coordinate investigations related to deviations, customer complaints, OOS, and other quality events.
- Prepare self-inspection plans, conduct inspections,



and follow up on observations until closure.
- Prepare Management Review Meeting presentations and compile quality metrics and performance data.
- Review BMRs, BPRs, and supporting batch documents for completeness, accuracy, and compliance.
- Verify batch release checklists and supporting documents in accordance with approved procedures.
- Perform batch disposition and release activities within authorized responsibilities and applicable quality procedures.
- Coordinate with Production, QC, Warehouse, and other departments for timely batch review and release.
- Receive, log, investigate, trend, and close customer and market complaints.
- Coordinate complaint investigations and ensure implementation of CAPA wherever required.
- Maintain QMS records, registers, trackers, and quality trending reports.
- Handle assigned quality software activities, electronic records, system monitoring, and report generation in accordance with approved procedures.
- Ensure Positive Documentation Practices (GDP), data integrity, and compliance with approved procedures.
- Perform other quality-related duties assigned by the Department Head or Management.

Preferred candidate profile

- B. Pharm or M. Pharm.
- B.Sc. / M.Sc. in Chemistry, Microbiology,
- Candidates should have knowledge of QMS, document control, cGMP, and applicable regulatory standards.
- For medical-device manufacturing, experience

📌 Senior Executive Quality Analyst (Bhiwadi)
🏢 Zuche Pharmaceuticals
📍 Bhiwadi