Assistant Manager Manager Quality Control QC

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

Job summary

HRV Pharma in Hyderabad, India, is seeking an experienced Assistant Manager/Manager - Quality Control to oversee daily analytical testing, instrument compliance, and quality operations across API and Formulation laboratories. You will lead a QC team, ensure data integrity, and drive investigations (OOS/OOT) and CAPA.

The role emphasizes method validation, transfers, instrument qualification (IQ/OQ/PQ), regulatory readiness, and adherence to USP/EP/BP/IP standards, with audits and client

Qualifications

• Education in a relevant science with advanced degree preferred.
• 8–10 years hands-on QC experience in pharma labs (API/Formulation).
• Strong knowledge of analytical techniques and regulatory requirements (USP/EP/BP/IP).
• Experience with CDS data review, audit trails, and CAPA.
• Leadership of QC teams and handling audits/regulatory inspections.

Responsibilities

• Direct daily QC testing workflows for timely release of materials and finished products.
• Oversee data systems, audit trails, user access, and data integrity for cGMP compliance.
• Lead OOS/OOT investigations and CAPA activities.
• Guide method validation, verification, and transfers; oversee stability studies.
• Supervise IQ/OQ/PQ activities and instrument calibration.
• Prepare for customer audits and regulatory inspections; close observations.
• Mentor and train QC chemists on cGLP practices and regulatory standards.

Skills

Analytical techniques

Data integrity

Regulatory compliance

cGMP/cGLP

QA leadership

Education

M.Sc. (Chemistry)

M.Pharm

B.Pharm

Tools

Empower

Chromeleon

LabSolutions

OpenLab

Job description

Job Overview

We are looking for an experienced and detail-oriented Assistant Manager / Manager - Quality Control to oversee daily analytical testing, instrument compliance, and quality operations across our pharmaceutical laboratories (API/Formulation). In this role, you will lead a team of QC analysts, manage chromatographic data integrity, direct laboratory investigations (OOS, OOT, CAPA), ensure pharmacopeial compliance (USP, EP, BP, IP), and represent the QC function during customer and regulatory audits.

Key Responsibilities

• Laboratory Operations & Release: Direct daily QC testing workflows to ensure the timely testing, review, approval, and analytical batch release of raw materials, intermediates, and finished products.
• Data Review & Audit Trails: Oversee electronic chromatographic data systems (Empower, Chromeleon, LabSolutions, OpenLab), conducting thorough data reviews, audit trail assessments, and user access management to maintain strict 21 CFR Part 11 / data integrity compliance.
• Laboratory Investigations: Spearhead root-cause investigations for Out of Specification (OOS), Out of Trend (OOT), laboratory incidents, and deviations; formulate and track robust Corrective and Preventive Actions (CAPA).
• Method Validation & Transfer: Guide and review analytical method validation (AMV), verification, method transfers, and long-term stability study protocols and execution.
• Equipment Qualification & Calibration: Supervise laboratory compliance programs, including instrument qualification (IQ/OQ/PQ), routine calibration, preventive maintenance, and chemical reference standard management.
• Audit & Inspection Readiness: Face and support customer audits, internal laboratory audits, and regulatory inspections, ensuring prompt closure of audit observations.
• Team Leadership & cGLP Training: Mentor, manage, and upskill laboratory chemists on cGLP practices, advanced analytical techniques, and regulatory compliance standards.

Qualifications & Requirements

• Education: M.Sc. (Chemistry), M.Pharm, or B.Pharm in a relevant scientific discipline.
• Experience: Minimum 8-10 years of hands-on experience in pharmaceutical Quality Control laboratories handling API and/or Formulation products.
• Analytical Expertise: Deep practical knowledge of analytical techniques, including HPLC, GC, UV, FTIR, ICP-MS, Dissolution testing, and Wet Chemistry.
• Chromatography Data Systems (CDS): Proven experience managing and reviewing data in systems such as Empower, Chromeleon, LabSolutions, or OpenLab, including audit trail reviews, user management, and data integrity enforcement.
• Investigations & CAPA: Proven expertise in leading laboratory failure investigations (OOS, OOT), deviations, and implementing effective CAPAs.
• Methodology & Stability: Solid background in analytical method validation (AMV), method transfer, method verification, and ICH stability studies.
• Regulatory & Pharmacopeia Standards: In-depth familiarity with pharmacopeial requirements (USP, EP, BP, IP), cGMP/cGLP guidelines, and global regulatory inspection expectations.
• Audits & Compliance: Proven track record of successfully handling client quality audits, internal assessments, and regulatory agency inspections.
• Leadership: Strong team management and operational capabilities to drive timely laboratory testing, report approvals, and data release.

Application Process

• Submit Application
• Initial Screening
• Technical Interview
• Final Discussion