Head of Quality Control

About Us

A reputable pharmaceutical manufacturer committed to high-quality pharmaceutical products, operating under GMP and local regulatory standards. Seeking an experienced QC Head to lead laboratory and quality control operations, ensure product release integrity, and drive continuous improvement.

Role Overview

Lead the Quality Control function for pharmaceutical manufacturing, ensuring analytical accuracy, regulatory compliance, and timely product release. Manage the QC laboratory, develop QC strategy, and act as a technical authority during audits and regulatory inspections.

Key responsibilities

Lead and manage the QC department including Analysts, microbiologists, and lab technicians.

Oversee analytical testing for raw materials, in-process samples, finished products, and stability

studies.

Approve release decisions for batches in accordance with specifications and SOPs.

Maintain compliance with cGMP/cGLP, PIC/S guidelines and local regulatory requirements.

Develop and implement QC SOPs, test methods, and validation programs. Support best practices

in Laboratory in terms of integrity, accuracy and adequacy of the testing and documentation.

Manage laboratory quality systems: deviation handling, CAPA, change control, OOS/OOT

investigations, and documentation control.

Coordinate regulatory inspections and supplier audits; prepare QC for site visits and responses.

Drive continuous improvement in test turnaround time, cost control, and method robustness.

Budgeting and resource planning for QC equipment, consumables, calibration, and maintenance.

Train and mentor QC staff; cultivate technical competence and Quality culture.

Technology Transfer: Co-ordination w.r.t Analytical Method Transfer for technology transfer

during new product launches.

Pharmacopoeia Compliance: Pharmacopoeia review of specifications and STP's and ensure the

compliance.

Ensure the laboratory computerized systems are validated in compliance with the quality policies,

standards and procedures and are maintained in validated state throughout the lifecycle.

Qualifications

Bachelor or Master Degree in Pharmacy, Chemistry, Pharmaceutical Science, or related discipline.

At least 15 years experience in pharmaceutical QC laboratories, with a minimum of 5 years in

managerial role.

Strong knowledge of GMP/GLP, stability testing, analytical techniques (HPLC, GC, UV, titration),

and microbiology testing.

Demonstrable experience handling OOS/OOT, method validation/transfer, and regulatory

inspections.

Excellent leadership, communication, and problem-solving skills.

Proficient in laboratory information systems

Proficiency in Power point presentations