Officer - Quality Control

Why This Role Matters

The officer – quality control ensures that all products released to the market meet required quality standards, customer specifications, and comply with applicable pharmacopoeias, cGMP, GLP, ICH, USFDA, and ISO guidelines. This role is critical for maintaining product integrity, safety, and reliability, supporting both manufacturing and regulatory compliance. By ensuring rigorous quality testing and analytical evaluation, the officer contributes directly to the company’s commitment to excellence in pharmaceutical production.

Job Description

The quality control officer is responsible for testing finished products, raw materials, in-process samples, and stability batches. The role involves performing wet and instrumental analyses, preparing trend reports, ensuring proper calibration of analytical instruments, and maintaining compliance with quality standards. The officer also coordinates with cross-functional teams to ensure smooth analytical workflows, addresses deviations, and supports method development and validation activities.

Key Features Of The Role

• Analysis of finished products, raw materials, in-process, and stability samples using wet and instrumental methods.
• Preparation of stability trends and sharing updates with stakeholders.
• Conducting LSC meetings to communicate stability status.
• Calibration of HPLCs as per defined procedures and schedules.
• Execution of method validations following applicable guidelines.
• Inventory management of reagents, columns, and spares required for analysis.
• Mobile phase preparation and accurate record keeping.
• Printing and preparation of analysis records.
• Logbook management for various analytical activities.
• Preparation or revision of methods of analysis.
• Revision/preparation of product specifications in consultation with purchase and other departments.
• Reporting deviations in analysis and implementing corrective and preventive actions (CAPA).
• Troubleshooting analytical instruments to ensure smooth workflow.
• Maintaining good housekeeping in the laboratory and surrounding areas.
• Conducting stability studies for premix validation and annual batches.
• Ensuring compliance with SHE guidelines and promoting safe working practices.

Responsibilities

• Perform analysis of raw materials, intermediates, finished products, and stability samples using HPLC, GC, GCHS, spectrophotometers, and other analytical instruments.
• Prepare, review, and communicate stability trends to stakeholders.
• Plan and execute instrument calibrations and method validations in compliance with cGMP/GLP.
• Maintain accurate documentation for all QC activities, including logbooks, analysis records, and mobile phase preparation.
• Manage reagent, column, and spare inventory for uninterrupted lab operations.
• Coordinate with other departments for specification revisions and method updates.
• Identify, report, and resolve deviations and ensure CAPA implementation.
• Troubleshoot analytical instruments to minimize downtime.
• Conduct stability studies for premix batches as required.
• Uphold lab safety standards and ensure adherence to SHE regulations.

Required Qualifications

Educational requirements
• Post-graduation in Chemistry.
• Knowledge of cGMP, GLP, ICH, USFDA, and ISO guidelines.

Experience and Skills
• Minimum 6 years of experience in the pharmaceutical industry, with extensive QC experience in API manufacturing.
• Proficient in method development and validation.
• Experienced in handling analytical instruments such as HPLC, GC, GCHS, spectrophotometers, and other lab equipment.
• Strong analytical, problem-solving, and documentation skills.
• Ability to maintain accuracy, reliability, and compliance under tight schedules.

Salary Insights

• Competitive salary based on experience and industry standards.
• Performance-based incentives and opportunities for career growth.
• Benefits include professional development, global exposure, and a collaborative work environment.

Company Overview

CENTRIENT is a global pharmaceutical company committed to delivering high-quality medicines worldwide. Operating across multiple countries, the company emphasizes innovation, regulatory compliance, and patient safety. CENTRIENT fosters a collaborative, high-performance culture where employees can grow professionally and make a meaningful impact in healthcare.

FAQs

Q: What products will the officer work with?
A: The officer will handle APIs, premixes, and finished dosage forms, ensuring compliance with quality standards and regulatory guidelines.

Q: Is prior QC experience in pharmaceuticals required?
A: Yes, extensive experience in QC within the pharmaceutical or API manufacturing industry is required.

Q: Will training be provided?
A: Yes, the company provides professional development and training for QC processes, instrument handling, and regulatory compliance.

Q: Is this role hands-on in the lab?
A: Yes, this is a hands-on role, involving routine analysis, method validation, and troubleshooting of laboratory instruments.

Application Tips

•Highlight experience in QC of APIs, premixes, and finished products.
•Demonstrate familiarity with cGMP, GLP, ICH, and USFDA guidelines.
•Showcase hands-on experience with HPLC, GC, spectrophotometers, and other analytical instruments.
•Include examples of method development, validation, and troubleshooting.
•Emphasize adherence to documentation, CAPA implementation, and lab safety practices.