Manager Quality Systems & Compliance

3+ years

Not Disclosed

Mumbai

10 March 4, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager – Quality Systems & Compliance

Location: Mumbai, India
Category: Quality

Designation:

Manager – Quality Systems & Compliance

Reporting To:

Head of Quality Assurance

Main Purpose of Role:

Ensure the effective implementation and continuous improvement of Quality Systems within the commercial affiliate.
Oversee regulatory compliance, supplier qualification, internal audits, and CAPA management.
Support product action readiness, quality risk management, and compliance with regulatory requirements.

Key Responsibilities:

1. Quality Systems Review & Implementation (30%)

Implement and maintain Quality policies relevant to the commercial affiliate.
Review and update the Quality Manual in alignment with regulatory standards.
Assess the impact of applicable regulations on Quality Systems.
Ensure product action readiness, maintaining product action procedures as per compliance requirements.
Track and manage Quality Objectives to ensure Affiliate QA meets compliance benchmarks.
Support and monitor the Affiliate Quality Management Review process.
Ensure FSSAI license validity tracking for applicable sites.
Maintain an approved distributor list and ensure its regular review.

2. Regulatory Compliance (20%)

Coordinate regulatory audits and inspections, ensuring timely follow-ups and compliance.
Implement Quality Metrics to drive improvements and ensure adherence to testing requirements.
Ensure compliance with Importation Testing requirements for India and Ex-India markets.
Maintain records and oversee Temporary Product Reassignment activities for Affiliate Quality.

3. Purchasing Control (30%)

Ensure compliance with OACA-SUP requirements and relevant purchasing control procedures.
Conduct monthly governance meetings, identifying risks and ensuring timely action.
Develop and maintain a supplier audit schedule and re-evaluation plan.
Monitor supplier performance, ensuring compliance with set timelines.
Perform supplier qualification audits, re-evaluations, and Approved Supplier List (ASL) updates.
Review purchase orders and identify quality risks, taking necessary corrective actions.
Oversee Supplier Corrective Action Requests (SCARs), ensuring timely closure.

4. Internal Audit & CAPA Management (20%)

Ensure compliance with internal audit procedures and OACA-CAPA guidelines.
Develop and implement the Internal Audit Program, ensuring stakeholder engagement.
Facilitate pre-audit preparations, document findings, and issue reports.
Upload audit findings into the SBM CAPA system as per requirements.
Track audit adherence and CAPA closure, conducting governance meetings for timely completion.
Support Root Cause Analysis (RCA) and CAPA review to ensure compliance.

Experience & Key Skills Required:

Team Management: Experience in handling a team within Quality Assurance.
Regulatory Compliance: Expertise in managing regulatory and external audits.
Quality Systems Implementation: Strong background in HACCP and Quality Systems.
Audit Expertise: Internal Audit/Lead Auditor certification in ISO 9001, FSSC 22000/BRC.
Analytical & Communication Skills: Strong proficiency in Power BI, MS Excel, and data-driven decision-making.
Stakeholder Management: Ability to collaborate effectively with cross-functional teams.

Preferred Certifications:

ISO, FSSC 22000, Quality Systems Certification
Lead Auditor for FSSC 22000

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Manager Quality Systems & Compliance

Job Description

Designation:

Reporting To:

Main Purpose of Role:

Key Responsibilities:

1. Quality Systems Review & Implementation (30%)

2. Regulatory Compliance (20%)

3. Purchasing Control (30%)

4. Internal Audit & CAPA Management (20%)

Experience & Key Skills Required:

Preferred Certifications:

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