Quality Assurance Manager

Role & responsibilities

• Quality Control Oversight:

QMS Documentations.

End to end Quality Management of all the pharmaceutical, nutraceuticals and OTC products.

Supervising and implementing quality control procedures for raw materials, intermediates and finished products.

Plan, execute, and oversee inspection and testing of all the products and packaging material to confirm quality to specifications and quality deliverables.

• Documentation Management: Ensuring accurate and up-to-date documentation, including COAs, SOPs, BMRs, and other quality-related records.
• Deviation Handling: Investigating and resolving deviations, non-conformances, and out-of-specification (OOS) results.
• Change Control: Managing change control processes, ensuring that changes to products or processes are properly evaluated, recorded and implemented.
• CAPA Management: Participating in the development and implementation of Corrective and Preventive Actions (CAPA) to address quality issues. Following up on Corrective and Preventive Actions (CAPA) for any quality gaps occurred.
• Artwork and Approvals: To ensure all Artworks are correct as per specific / statutory / company requirements and are cleared / approved on day-to-day basis
• Audit Participation: Participating in internal and external audits, including regulatory and customer audits, to assess compliance with quality standards. Conducting various types of audits (project documentation, Facility, Method, Internal and Process audits), Development, review, revise and implement SOPs as required by the regulatory requirements and to ensure compliance as per applicable regulatory requirements.
• Training and Mentoring: Training and mentoring QA staff and other personnel on quality procedures and GMP requirements.
• Collaboration: Collaborating with other departments, such as Purchase, Design, Production, Research & Development, and QC, to resolve quality issues and improve processes.
• Compliance: Ensuring compliance with relevant regulations, including GMP, ISO standards, and other applicable guidelines.Ensuring the product pricing are aligned as per the DPCO guidelines.

Knowledge of The Drugs and Magic Remedies Act and The Drugs and Cosmetics Act

• Continuous Improvement: Identifying areas for quality improvement and participating in initiatives to enhance quality performance.

Preferred candidate profile

• Experience: 10 15 years of experience in Quality Assurance within the pharmaceutical industry. Experience in IPQA (In-Process Quality Assurance) .
• Knowledge: Strong knowledge of GMP, GLP, ISO standards, documentation related to quality and regulatory guidelines and regulatory requirements.
• Technical Skills: Proficiency in quality systems, deviation handling, root cause analysis, change control, and validation processes.
• Soft Skills: Strong leadership, communication, problem-solving, and decision-making abilities.
• Analytical Skills: Ability to analyse quality data, identify trends, and propose solutions.