Zydus Wellness - Senior Manager - Quality (10-15 yrs)
Reporting: Head Quality & Regulatory
Direct Reports: 4
Ensure compliance to laid down standards and procedures, lead Factory Quality for strategic and operational quality initiative implementation, ensure sustenance of Quality and Food Safety standards protocol, processes and procedures for delivering superior quality and safe food products out of the factory
Internal - Cross Functional Heads, Corporate, R&D, Supply Chain
External - Regulatory Department, Vendors
Qualification: M.Pharma/M.Sc (Chemistry)/PG
Experience: 10 - 12 years of work experience, at least 2 years in Managerial position
Preferred Age Group: 35 -38 years
Technical Competencies: Good knowledge in Pharmaceutical formulation, Product Safety Systems and certification, Good knowledge in Drug and Cosmetic Act, FSSAI, legal metrology, Quality Control Instrumentation
- Behavioral Competencies: Strong leadership with ability to manage and develop team
- Ensure QC/QA Systems & procedures development, implementation, monitoring and sustenance at factory.
- Ensure Compliance to organisation Product Safety/Quality/Regulatory requirements.
- Responsible for Laboratory operations that includes complete testing regime includes testing plan, method developments, analytical method validations, materials testing's includes wet lab and instrumentation lab handling.
- Well versed with latest analytical equipment's that include UV, IR, HPLC, GC, HPTLC, NMR etc.
- Ensure continuous audits/monitoring to ensure compliance to defined QA requirements in all activities at plant.
- Ensure the complete material testing regime, laboratory operations as per the industry best standards.
- Ensure to handle and support all types of OOS, Non conformity, product failures, process failures, and strong CAPA implementations, validations, NPD's.
- Ensure to handle site QA budget regime that includes preparation, allocation, and handling.
- Ensure the complete pest control, calibrations, AMC's regime at factory
- Ensure to implement Quality and Product Safety management systems as per the international standards and compliance of the same.
- Support business in handling Supplier Quality Assurance regime that includes vendor audit, develop and manage RM, PM vendors and forward supply chain.
- Lead role in ensuring factory Regulatory Affairs (RA) compliance as per the requirements of Drug & Cosmetic Act, FSSAI, legal metrology.
- Handling and managing Consumer Complaints.
- Lead role in managing and complying to ISO 9001, ISO 22716, ISO 22000/HACCP, OHSAS 18001, ISO 14001 certifications.
- Manage, develop and steer the team to the best performing level.
- Good knowledge in SAP working and especially in QM module.
- Lead the implementation of QMS & FSMS at factory.
- An excellent People Manager and leader, able to inspire develop and retain high caliber talent
- Ability to energize team with clear vision of business
- Ability to work on Capability Building of team to create future pipeline