JOB DESCRIPTION

HEAD - QUALITY CONTROL

Company

BDR Lifesciences Private Limited - A Group Company of BDR Pharmaceuticals International Pvt. Ltd.

Business

Active Pharmaceutical Ingredients (API)

Location

Padra, Vadodara, Gujarat

Grade

AGM / DGM / GM

Experience

15+ years of relevant experience in pharmaceutical Quality Control, with strong API exposure

Reporting To

Site Head / Director - Technical Operations / Corporate Quality Head, as per approved organisation structure

Compensation

Market-aligned CTC, subject to internal parity

Employment Type

Full-time

1. Company Overview

BDR Lifesciences Private Limited is the API business arm of the BDR Group and operates as a group company of BDR Pharmaceuticals International Pvt. Ltd. The organisation is engaged in the development and manufacturing of Active Pharmaceutical Ingredients, with a strong focus on quality, regulatory compliance, operational excellence and customer requirements. The company serves regulated and semi-regulated markets and is committed to maintaining robust pharmaceutical quality systems aligned with applicable national and international regulatory standards.

2. Position Purpose

The Head - Quality Control will provide strategic, technical and operational leadership to the complete Quality Control function at the API manufacturing facility in Padra, Vadodara. The incumbent will ensure that all materials, intermediates, in-process samples, finished APIs, stability samples, water samples and environmental samples are tested, reviewed and reported in compliance with approved specifications, pharmacopoeial requirements, regulatory commitments and internal quality systems.

The role requires strong command over analytical chemistry, API testing, laboratory investigations, data integrity, regulatory audits, method validation and transfer, stability management, laboratory compliance, capacity planning and team leadership. The position is accountable for the reliability, accuracy, traceability and regulatory acceptability of analytical data generated by the Quality Control laboratory.

3. Key Responsibilities

A. Quality Control Leadership

- Lead the complete Quality Control function covering chemical, instrumental, microbiological and stability testing activities, wherever applicable.
- Develop and implement the annual Quality Control strategy, departmental objectives, manpower plan, capital expenditure plan and laboratory improvement roadmap.
- Ensure timely testing, review, approval and release of materials and products without compromising quality or regulatory compliance.
- Establish clear accountability, productivity standards and performance metrics for the Quality Control team.
- Provide technical guidance to laboratory managers, section heads, analysts, microbiologists and supporting personnel.
- Ensure effective coordination with Quality Assurance, Production, Warehouse, Engineering, EHS, Regulatory Affairs, R&D; and Supply Chain functions.

B. API Testing and Laboratory Operations

- Ensure testing of raw materials, solvents, intermediates, in-process samples, finished APIs, packing materials, water and stability samples as per approved specifications and test procedures.
- Ensure all laboratory testing is performed in accordance with Good Laboratory Practices, Good Manufacturing Practices and approved standard operating procedures.
- Review and approve analytical data, certificates of analysis, laboratory worksheets, chromatograms, audit trails and associated documentation.
- Ensure appropriate sampling, testing, retesting, retention sample and reference standard practices.
- Monitor laboratory turnaround time and ensure timely availability of analytical results to support manufacturing and dispatch schedules.
- Maintain adequate laboratory capacity, instrument availability and manpower deployment to support business requirements.

C. Regulatory Compliance and Inspection Readiness

- Ensure compliance with applicable requirements of USFDA, EU-GMP, WHO-GMP, ICH, Schedule M, CDSCO and other relevant regulatory authorities.
- Maintain the laboratory in a state of continuous inspection readiness.
- Lead Quality Control preparations for regulatory inspections, customer audits, due diligence audits and internal audits.
- Represent the Quality Control function during inspections and provide accurate, scientifically justified responses to observations and queries.




- Ensure timely implementation and closure of Corrective and Preventive Actions arising from audits and inspections.
- Review and strengthen laboratory systems based on evolving regulatory expectations and industry practices.

D. Data Integrity and Documentation

- Ensure compliance with ALCOA+ principles across all laboratory activities, records and electronic systems.
- Maintain effective controls over electronic records, audit trails, user access, data acquisition, processing, review, backup and archival.
- Ensure laboratory notebooks, worksheets, logbooks, chromatograms, spectra and electronic data are complete, accurate, traceable and contemporaneous.
- Ensure periodic audit-trail review and escalation of any suspected data-integrity concern.
- Promote a strong culture of ethical documentation, transparent reporting and zero tolerance for data manipulation.

E. Laboratory Investigations

- Lead and review investigations related to Out-of-Specification, Out-of-Trend, atypical results, invalid tests, laboratory errors and analytical discrepancies.
- Ensure investigations are scientifically sound, timely, unbiased and adequately documented.
- Oversee laboratory hypothesis testing, root-cause analysis and impact assessment.
- Ensure retesting and resampling decisions are based on approved procedures and scientific justification.
- Monitor recurring laboratory failures and implement systemic corrective actions.
- Present investigation trends and critical findings in management and quality review forums.

F. Stability Management

- Ensure preparation and execution of stability protocols in line with regulatory requirements and approved programmes.
- Monitor stability sample charging, withdrawal, testing, review and reporting schedules.
- Review stability data for trends, deviations and potential product quality concerns.
- Ensure timely investigation and escalation of Out-of-Trend or Out-of-Specification stability results.
- Support preparation of stability data for regulatory submissions, customer requirements and product lifecycle management.
- Ensure stability chambers are appropriately qualified, monitored and maintained.

G. Instrumentation and Laboratory Systems

- Ensure qualification, calibration, preventive maintenance and performance verification of laboratory instruments.
- Oversee instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, Polarimeter, TOC Analyser and other relevant equipment.
- Ensure instrument breakdowns are addressed promptly and adequate backup arrangements are available.
- Participate in selection, procurement, commissioning and lifecycle management of laboratory instruments and technologies.
- Ensure computerised systems used in the laboratory are validated and compliant.
- Drive laboratory automation and digitalisation, including LIMS and electronic data-management systems.

H. Microbiology and Water Testing

- Oversee microbiological testing activities, wherever applicable to the API facility.
- Ensure monitoring and testing of purified water, potable water, environmental samples and microbial limits as applicable.
- Review microbiological trends and ensure timely investigation of excursions.
- Ensure effective control of media, cultures, incubation conditions and laboratory practices.
- Coordinate with Production, Engineering and Quality Assurance for water-system and environmental-monitoring investigations.

I. Deviations, Change Control, CAPA and Risk Management

- Review and approve Quality Control-related deviations, change controls, laboratory incidents and CAPAs.
- Evaluate the analytical impact of proposed changes in processes, specifications, methods, instruments, software, vendors or raw materials.
- Ensure timely implementation and effectiveness verification of CAPAs.
- Participate in cross-functional investigations and risk assessments.
- Apply Quality Risk Management principles to laboratory systems, analytical methods and testing processes.
- Identify critical laboratory risks and establish proportionate controls.

J. Specifications,



Pharmacopoeial Compliance and Product Release Support

- Review and approve specifications and standard test procedures for raw materials, intermediates, finished APIs and packing materials.
- Ensure specifications are aligned with regulatory submissions, customer requirements, pharmacopoeias and product quality requirements.
- Assess and implement changes in IP, USP, BP, EP, JP and other applicable pharmacopoeias.
- Ensure timely completion of testing and analytical documentation required for batch release.
- Ensure certificates of analysis are accurate and aligned with approved specifications and customer requirements.
- Provide analytical inputs for batch disposition decisions and customer complaint investigations.

K. Customer and Regulatory Support

- Respond to customer technical queries, questionnaires and requests related to analytical testing and Quality Control systems.
- Support regulatory filings by providing analytical data, validation reports, stability data, specifications and supporting documents.
- Participate in technical discussions with customers, regulatory agencies and business partners.
- Support site transfers, product transfers, customer-specific testing and regulatory commitments.

L. Budgeting, Productivity and Continuous Improvement

- Prepare and manage the annual Quality Control operating and capital expenditure budget.
- Monitor expenditure on laboratory chemicals, columns, standards, reagents, consumables, instruments and external testing.
- Optimise laboratory costs without compromising compliance or analytical quality.
- Drive improvements in turnaround time, right-first-time testing, investigation closure, instrument utilisation and documentation quality.
- Implement Lean Laboratory, 5S, visual management and workflow-optimisation initiatives.
- Benchmark laboratory systems against industry best practices and promote adoption of current analytical technologies.

M. Team Leadership and Capability Development

- Build, develop and retain a competent, disciplined and performance-oriented Quality Control team.
- Define departmental structures, roles, responsibilities, delegation levels and succession plans.
- Ensure employees are appropriately qualified, trained and authorised before performing assigned activities.
- Conduct technical, GMP, data-integrity and behavioural development programmes.
- Mentor high-potential employees and develop second-line leadership.
- Drive a culture of ownership, scientific thinking, integrity, accountability and continuous improvement.

4. Qualification and Experience

Essential Qualification

- M.Sc. in Chemistry, Analytical Chemistry, Organic Chemistry, Pharmaceutical Chemistry or a related scientific discipline.
- M.Pharm. in Pharmaceutical Analysis or Quality Assurance may also be considered.

Preferred Qualification

- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences or a relevant discipline.
- Certification in Quality Management, Regulatory Compliance, Data Integrity, Lean Six Sigma or Laboratory Management.

Experience Requirements

- Minimum 15 years of progressive experience in pharmaceutical Quality Control.
- Significant experience in an API manufacturing environment is mandatory.
- At least 5 years of experience in a senior Quality Control leadership role and should have handled USFDA audits.
- Experience in regulated-market requirements and inspections is strongly preferred.
- Demonstrated experience in analytical investigations, laboratory compliance, method validation, stability studies and data integrity.
- Experience in managing a sizeable Quality Control team and multiple laboratory sections.
- Exposure to oncology APIs, complex molecules, high-potency APIs or specialised API manufacturing will be an added advantage.

5. Ideal Candidate Profile

The ideal candidate will be a mature and technically strong Quality Control leader with substantial experience in API manufacturing and regulated pharmaceutical environments. The individual should be capable of balancing stringent regulatory compliance with operational responsiveness and business requirements, while demonstrating strong command over laboratory investigations, analytical science, data integrity and inspection readiness. The candidate must possess the leadership maturity required to build a disciplined, scientifically competent and accountable Quality Control organisation capable of supporting the future growth of BDR Lifesciences.

📌 QC Head (Vadodara)
🏢 BDR Pharmaceuticals
📍 Vadodara