Quality Assurance
1 day ago
This role is for one of the Weekday's clientsSalary range: Rs Rs ie INR 1-10 LPA)Min Experience: 8 yearsLocation: Chengalpattu, ChennaiJobType: full-timeWe are seeking an experienced Quality Assurance (QA) Specialist with deep expertise in Active Pharmaceutical Ingredients (API) to ensure the highest standards of product quality, regulatory compliance, and operational excellence across our manufacturing processes. This role requires a strong understanding of GMP guidelines, quality systems, process validation, deviation management, and end-to-end oversight of API production. The ideal candidate will be meticulous, proactive, and capable of partnering with cross-functional teams to drive continuous improvement and ensure audit readiness.RequirementsKey Responsibilities Oversee and maintain Quality Assurance processes for API manufacturing in alignment with cGMP, ICH, WHO, and other global regulatory requirements. Review and approve master batch records, manufacturing instructions, process flow documents, and analytical methods related to APIs. Monitor in-process quality during API production, ensuring compliance with validated parameters and approved procedures. Lead quality reviews of deviations, change controls, CAPA, OOS/OOT investigations, and ensure timely closure with robust root-cause analysis. Support process validation, cleaning validation, method validation, and equipment qualification activities. Conduct risk assessments using tools such as FMEA, HACCP, and Quality Risk Management principles to identify and mitigate risks across production and testing stages. Work closely with Production, QC, Regulatory Affairs, Engineering, and Supply Chain teams to maintain consistent quality standards. Participate in self-inspections, internal audits, and external audits (USFDA, EMA, MHRA, WHO, etc.), providing necessary documentation and responses. Review and approve vendor qualification documents, raw material specifications, and API release documentation. Support data integrity initiatives, ensuring adherence to ALCOA+ principles and maintaining robust control over electronic and paper-based systems. Ensure timely review and release of API batches, ensuring all documentation complies with regulatory and quality requirements. Implement continuous improvement initiatives to enhance process capability, reduce variability, and strengthen overall quality systems. Train production and quality teams on SOPs, GMP compliance, data integrity, and investigation procedures. Monitor market complaints, stability programs, and product quality trends, initiating investigations and corrective actions where necessary. Requirements Bachelor's/Master's degree in Pharmacy, Chemical Engineering, Biotechnology, or related field. 8–10 years of hands-on experience in QA within API or bulk drug manufacturing environments. Strong understanding of API production processes, reaction chemistry, process controls, and manufacturing operations. In-depth knowledge of cGMP, ICH Q7, regulatory guidelines, and global audit requirements. Proven experience in managing deviations, CAPA, OOS investigations, and technical documentation. Familiarity with analytical instruments, chromatographic techniques, and lab data review for API testing. Excellent documentation, communication, and cross-functional collaboration skills. Demonstrated ability to work under pressure, manage multiple priorities, and support time-bound deliverables. Strong problem-solving, risk assessment, and decision-making capabilities.
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