Assistant Manager / Manager – Quality Assurance (QA)

HRV Pharma; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

HRV Pharma in Hyderabad, India, seeks an experienced Assistant Manager / Manager – Quality Assurance (QA) to lead QA operations across API and Formulation facilities. The role oversees QMS, regulatory audits, qualification and validation programs, and vendor audits, ensuring compliance with cGMP standards.

The candidate will drive CAPA, deviation investigations, APQR, and batch release review, while mentoring the QA team and collaborating with Production, QC, Regulatory Affairs, and Supply Chain

Qualifications

• M.Sc., M.Pharm, or B.Pharm in a relevant scientific discipline.
• 8–10 years of hands‑on Quality Assurance experience within API and/or Formulation pharmaceutical manufacturing facilities.
• In‑depth mastery of cGMP, ICH guidelines, WHO, USFDA, EU GMP, PIC/S, and related statutory pharmaceutical regulations.
• Proven expertise managing end-to-end Quality Management Systems, including Change Control, Deviations, CAPA, OOS/OOT investigation root cause analysis, Quality Risk Management (QRM), and APQR.
• Practical expertise overseeing Process Validation, Cleaning Validation, Analytical Method Validation, and Equipment/Utility Qualification.
• Strong track record facing regulatory agency inspections (USFDA, EU GMP, etc.), customer audits, and leading external vendor GMP audits.
• Experience managing customer complaints, market returns, product recall workflows, contract manufacturing sites (CMOs), and contract analytical testing labs.
• Proven ability to critically review and approve SOPs, specifications, validation protocols/reports, and batch production records.
• Strong team management, interpersonal communication, and cross‑functional leadership skills.

Responsibilities

• Lead end-to-end QMS operations, ensuring thorough handling and timely closure of Change Controls, Deviations, CAPA, OOS/OOT investigations, Risk Assessments, and APQR.
• Review and approve core quality documentation, including SOPs, master specifications, qualification protocols, validation reports, and BMR/BPR.
• Serve as primary QA coordinator for regulatory inspections (USFDA, EU GMP, WHO, PIC/S, etc.), customer audits, internal GMP audits, and external vendor compliance reviews.
• Direct qualification and validation lifecycles across the facility, covering Process Validation, Cleaning Validation, Analytical Method Validation (AMV), and Equipment/Utility Qualification (IQ/OQ/PQ).
• Oversee vendor qualification audits, external contract testing laboratories, and contract manufacturing organizations (CMOs).
• Manage customer complaints, product returns, failure investigations, and product recall procedures in full alignment with international guidelines.
• Direct and mentor the QA operational team, working closely with Production, QC, Regulatory Affairs, and Supply Chain to drive continuous GMP compliance.

Skills

Quality Assurance

Regulatory understanding

Leadership

Cross-functional collaboration

Audits

Education

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

Job description

Home / Careers / Assistant Manager / Manager – Quality Assurance (QA)

Assistant Manager / Manager – Quality Assurance (QA)

We are seeking an experienced Assistant Manager / Manager – Quality Assurance (QA) to lead our pharmaceutical quality management operations across API and Formulation facilities. This role oversees site Quality Management Systems (QMS), drives regulatory audit compliance (USFDA, EU GMP, WHO, PIC/S), directs qualification and validation programs, and manages vendor audits, complaints, and product recalls. The position collaborates cross-functionally to uphold cGMP governance and ensure every batch meets strict regulatory and customer standards.

Key Responsibilities

Quality Management Systems (QMS): Lead and govern end-to-end QMS operations, ensuring thorough handling and timely closure of Change Controls, Deviations, CAPA, OOS/OOT investigations, Risk Assessments, and Annual Product Quality Reviews (APQR).

Document Review & Batch Release: Review and approve core quality documentation, including Standard Operating Procedures (SOPs), master specifications, qualification protocols, validation reports, and Batch Manufacturing/Packaging Records (BMR/BPR).

Audits & Regulatory Inspections: Serve as a primary QA coordinator for regulatory inspections (USFDA, EU GMP, WHO, PIC/S, etc.), customer audits, internal GMP audits, and external vendor compliance reviews.

Validation & Qualification Oversight: Direct qualification and validation lifecycles across the facility, covering Process Validation, Cleaning Validation, Analytical Method Validation (AMV), and Equipment/Utility Qualification (IQ/OQ/PQ).

External Partner & Vendor Governance: Oversee vendor qualification audits, external contract testing laboratories, and contract manufacturing organizations (CMOs).

Market Quality & Escalations: Manage customer complaints, product returns, failure investigations, and product recall procedures in full alignment with international guidelines.

Cross-Functional Leadership: Direct and mentor the QA operational team, working closely with Production, QC, Regulatory Affairs, and Supply Chain to drive continuous GMP compliance.

Qualifications & Requirements

• Education: M.Sc., M.Pharm, or B.Pharm in a relevant scientific discipline.
• Experience: Minimum 8–10 years of hands‑on Quality Assurance experience within API and/or Formulation pharmaceutical manufacturing facilities.
• Regulatory Frameworks: In‑depth mastery of cGMP, ICH guidelines, WHO, USFDA, EU GMP, PIC/S, and related statutory pharmaceutical regulations.
• QMS Operations: Proven expertise managing end-to-end Quality Management Systems, including Change Control, Deviations, CAPA, OOS/OOT investigation root cause analysis, Quality Risk Management (QRM), and APQR.
• Validation & Qualification: Practical expertise overseeing Process Validation, Cleaning Validation, Analytical Method Validation, and Equipment/Utility Qualification.
• Audits & Inspections: Strong track record facing regulatory agency inspections (USFDA, EU GMP, etc.), customer audits, and leading external vendor GMP audits.
• Third-Party Oversight: Experience managing customer complaints, market returns, product recall workflows, contract manufacturing sites (CMOs), and contract analytical testing labs.
• Documentation: Proven ability to critically review and approve SOPs, specifications, validation protocols/reports, and batch production records.
• Leadership: Strong team management, interpersonal communication, and cross‑functional leadership skills.