Manager / Sr. Manager - Quality Assurance

Role & responsibilities

• To Develop, implement, and maintain the Quality Management System (QMS), IMS / ISO (ISO 9001, ISO 14001 & ISO 45001) and applicable GMP requirements across the organization.
• Ensure compliance with REACH, Kosher, NABL, GLP requirements, customer related processes (Customer requirements, Customer complaints, Customer audits) and applicable statutory regulations.
• Review and control SOPs, specifications, quality manuals, and other controlled documents. Manage change control processes for changes made in documentation.
• Ensure proper documentation control, record retention, and data integrity practices including handling of vendor questionnaire.
• Monitor and review manufacturing processes to ensure adherence to approved procedures and quality standards in BMR.
• Plan,conduct, and coordinate internal, customer, regulatory, and certification audits and ensure timely closure of audit all observations and compliance gaps.
• Lead investigations of deviations, non-conformances, customer complaints,incidents etc.. related to quality and drive RCA & CAPA (Corrective and Preventive Action) implementation and monitor effectiveness during different plant rounds.
• Oversee qualification and validation activities, including equipment, process, cleaning, and utility validation.
• Establish quality metrics / KPIs and present quality performance reports to management.
• Manage supplier quality assurance programs, vendor qualification, and supplier audits.
• Lead, train, mentor, and develop the QA & whole team of different departments while promoting a strong quality culture.
• Drive continuous improvement initiatives to enhance product quality, regulatory compliance, customer satisfaction, and operational excellence.
• Certification / hands on experience in different management systems such as ISO (9001, 14001 & 45001) systems, Quality Management Systems, 5 S philosophy, 8 D analysis, Six Sigma, or different 7 Quality Tools are desirable.

Educational Qualification

• M.Sc. (Chemistry) with minimum 12-year experience and 05 years of relevant experience with good administration background.
• Ph. D. with minimum 8 year experience and 04 years of relevant experience.
• Exposure to Packaging development, resolution of queries related to IMDG, IATA and other export related labelling will be added requirements.

Preferred candidate profile

• 10-15 years (M. Sc.) & 8 -9 years (Ph. D.) of experience in Quality Assurance within Pharma Intermediates, Specialty Chemicals, Agrochemicals, Fine Chemicals, or Chemical Manufacturing industries. Minimum 5 (M. SC.) & 4 (Ph. D.) years of experience in a managerial role with good administrative background.
• Exposure to Packaging development, resolution of queries related to IMDG, IATA and other export related labelling will be added requirements.
• Handling customer audits, customer complaints, ISO audits, and quality systems implementation.