Assistant Manager Manager Quality Assurance QA

HRV Pharma; Hyderabad; On-site; INR 1,400,000 - 2,300,000; Full time

Job summary

HRV Pharma is seeking an experienced Assistant Manager / Manager – Quality Assurance (QA) to lead QA operations across API and Formulation facilities in Hyderabad. The role oversees QMS, regulatory audits (USFDA, EU GMP, WHO, PIC/S), vendor audits, CAPA, OOS/OOT investigations, and product recalls.

You will guide cross‑functional teams to uphold cGMP governance and batch quality. The ideal candidate has 8–10 years of hands‑on QA experience in pharma manufacturing, with deep knowledge of cGMP and

Qualifications

• Education: M.Sc., M.Pharm, or B.Pharm in a relevant scientific discipline.
• Experience: 8–10 years of QA experience in API and/or Formulation manufacturing facilities.
• Regulatory knowledge: deep mastery of cGMP, ICH, WHO, USFDA, EU GMP, PIC/S regulations.
• QMS operations: end‑to‑end QA management including Change Control, Deviations, CAPA, OOS/OOT, QRM, APQR.
• Validation/Qualification: oversee Process, Cleaning, Analytical Method Validation and IQ/OQ/PQ.
• Audits/Inspections: experience with regulatory inspections and external vendor GMP audits.
• Documentation: review and approve SOPs, specs, validation protocols/reports, and BMR/BPR.
• Leadership: strong team and cross‑functional leadership skills.

Responsibilities

• Lead and govern end‑to‑end QMS operations across API and Formulation facilities.
• Review and approve core quality documentation including SOPs, specs, protocols, and batch records.
• Coordinate regulatory inspections, customer audits, internal GMP audits, and vendor reviews.
• Direct qualification and validation lifecycles ( Process, Cleaning, AMV, IQ/OQ/PQ ).
• Oversee vendor qualification, external labs, and CMOs compliance.
• Manage customer complaints, product recalls, and market returns per guidelines.
• Mentor and lead QA team in collaboration with Production, QC, Regulatory, and Supply Chain.

Skills

QMS Management

Regulatory Compliance

Audits & Inspections

Validation & Qualification

Vendor Management

Team Leadership

Education

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

Job description

Job Description:

Job Overview

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.

Application Process

1. 1
   Submit Application
   Complete the application form below with your details and CV
2. 2
   Initial Screening
   Our HR team will review your application and contact suitable candidates
3. 3
   Technical Interview
   Selected candidates will have a technical interview with the department head
4. 4
   Final Discussion
   Final round with senior leadership team and offer discussion