Quality Assurance Officer - API

Why This Role Matters

The Quality Assurance Officer – API ensures that all products released to the market meet customer specifications, regulatory requirements, and internal quality standards. This role is critical in maintaining product safety, compliance, and reliability across the manufacturing lifecycle. By overseeing batch release, audits, and deviation management, the officer supports regulatory compliance, product integrity, and continuous improvement, helping the company deliver high-quality pharmaceutical products globally.

Job Description

The Quality Assurance Officer – API is responsible for maintaining quality standards for raw materials, intermediates, and finished products in compliance with cGMP, GLP, ICH, USFDA, ISO, and other applicable regulatory guidelines. The role involves batch release, documentation review, audit participation, investigation of deviations, and SHE compliance. The officer will collaborate with cross-functional teams, including Production, QC, Regulatory Affairs, and SHE, to ensure smooth and compliant operations across all manufacturing activities.

Key Features of the Role

•Participate in vendor qualification activities to ensure supplier compliance with quality and regulatory standards.
•Support internal and external audit activities, ensuring timely closure of observations and recommendations.
•Ensure compliance with applicable regulatory requirements, company SOPs, and quality standards.
•Review and release/reject finished products, intermediates, and raw materials according to approved specifications.
•Create and release Certificates of Analysis (CoA) for batches.
•Issue and review Batch Production Records (BPR) to ensure completeness and accuracy.
•Review QC analytical data for compliance with defined specifications.
•Handle sales returns, recalls, and compile Annual Product Review (APR) data.
•Coordinate investigations of market complaints, deviations, Out of Specification (OOS), and Out of Trend (OOT) events.
•Maintain logbooks for various QA and manufacturing activities.
•Ensure proper sampling of finished products per defined procedures and maintain compliance with cGMP practices.
•Ensure adherence to all SHE (Safety, Health, Environment) guidelines and promote safe working practices.
•Conduct monthly safety audits and ensure closure of observations.
•Report near misses, incidents, and unsafe conditions promptly.
•Ensure all SHE-related guidelines are followed during activities to maintain a safe working environment.
•Clear safety work permits to facilitate safe execution of manufacturing and QA activities.
•Release batches of intermediates and finished goods in SAP accurately and timely.

Responsibilities

•Oversee batch release for raw materials, intermediates, and finished products, ensuring compliance with specifications and regulatory requirements.
•Participate in supplier qualification and audits to maintain supply chain quality standards.
•Support internal and external audits, including preparation of documentation, follow-up, and closure of audit observations.
•Review and approve QC data, Certificates of Analysis, and Batch Production Records.
•Coordinate and investigate deviations, OOS, and market complaints, ensuring timely CAPA implementation.
•Prepare and compile Annual Product Review (APR) data to identify trends and areas for improvement.
•Monitor and ensure compliance with all regulatory requirements, cGMP, GLP, ICH, USFDA, and ISO guidelines.
•Maintain comprehensive and accurate records of QA activities, including logbooks, sampling records, and documentation related to SHE and regulatory compliance.
•Support method development, validation, and verification activities in collaboration with QC and production teams.
•Implement and enforce safe working practices, including SHE compliance audits and work permit approvals.
•Collaborate with cross-functional teams to drive continuous improvement in quality systems and regulatory compliance.

Required qualifications

Educational requirements
•Post-graduation in Chemistry.
•Thorough knowledge of cGMP, GLP, ICH, USFDA, and ISO guidelines.
•Familiarity with QA documentation, regulatory filings, and batch review processes.

Experience and Skills

•Minimum 9 years of experience in the pharmaceutical industry with extensive QA experience in API manufacturing.
•Experience in batch release, deviation handling, audits, CAPA implementation, and regulatory compliance.
•Proficiency in SAP or similar ERP systems for batch release and QA documentation.
•Strong analytical, problem-solving, and decision-making skills.
•Excellent documentation and record-keeping practices.
•Ability to handle multiple priorities while maintaining compliance and accuracy.
•Hands-on experience in implementing and monitoring SHE compliance in the manufacturing environment.

Salary Insights

•Competitive salary based on experience and industry standards.
•Performance-based incentives and opportunities for career growth.
•Benefits include professional development programs, global exposure, and a collaborative, high-performance 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 and inclusive culture, providing employees with opportunities to grow professionally and make a meaningful impact in healthcare.

FAQs

Q: What products will the officer handle?
A: The officer will handle raw materials, intermediates, and finished products, ensuring compliance with quality and regulatory standards.

Q: Will this role involve audits?
A: Yes, the officer will participate in internal and external audits and support closure of all observations.

Q: Is prior QA experience in pharmaceuticals required?
A: Yes, extensive QA experience in API or pharmaceutical manufacturing is mandatory.

Q: Will this role be hands-on?
A: Yes, the role involves hands-on batch release, documentation review, and SHE compliance activities.

Application Tips

•Highlight experience in QA of APIs, intermediates, and finished products.
•Demonstrate knowledge of cGMP, GLP, ICH, USFDA, and ISO guidelines.
•Include experience with batch release, deviation handling, audits, and CAPA implementation.
•Showcase ability to manage QA documentation, SAP processes, and compliance with SHE standards.
•Emphasize problem-solving skills, attention to detail, and regulatory compliance expertise.