Quality Assurance

This role is for one of the Weekday's clients

Salary range: Rs 100000 - Rs 1000000 (ie INR 1-10 LPA)

Requirements

Key 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