Senior Executive Quality Analyst

Zuche Pharmaceuticals Pvt. Ltd.; Bhiwadi; Presencial; INR 800.000 - 1.200.000; Jornada completa

Descripción de la vacante

Zuche Pharmaceuticals Pvt. Ltd. is seeking a quality professional to manage the Quality Management System (QMS) including document control, SOP preparation and revision, CAPA, Change Control and batch release activities.

The role ensures adherence to cGMP, ISO 13485:2016 and data integrity across regulated processes. Responsibilities include coordinating cross‑functional document control, batch review, deviations investigations and customer complaints, while maintaining GDP and regulatory

Formación

• Knowledge of QMS, document control, cGMP and applicable regulatory standards.
• Experience with ISO 13485:2016 and data integrity.
• Familiarity with batch documentation review, approval workflows and GDP.

Responsabilidades

• Prepare, review, issue, revise and archive SOPs and controlled documents.
• Coordinate cross‑department reviews for document control and implementation.
• Manage document issuance, retrieval and control per Document Control System.
• Lead CAPA, Change Control, Deviations and Customer Complaints processes.
• Ensure QMS compliance with ISO 13485:2016 and regulatory requirements.
• Maintain calibration, qualification, validation, and preventive maintenance matrices.
• Review and ensure completeness of batch records and release documents.
• Coordinate batch review and release with Production, QC and other teams.
• Conduct self‑inspection planning, execution and closure of observations.
• Prepare Management Review presentations and quality metrics reports.
• Maintain QMS records, trackers and quality trending data.
• Handle electronic records, GDP, data integrity and related activities.

Conocimientos

QMS

Document control

CAPA

Change Control

Regulatory compliance

Data integrity

GDP

Educación

B.Pharm

M.Pharm

BSc/ MSc in Chemistry

MSc in Microbiology

Descripción del empleo

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 Good 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