Site Quality Manager - Factory

Job Title - Site Quality Manager - Sikkim - Leading Consumer Brand

Location - Sikkim

Team - 4 people

Job Details : 

Job Purpose: 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

Key Stakeholders: Internal - Cross Functional Heads, Corporate, R&D, Supply Chain

External - Regulatory Department, Vendors

Pre-requisite Role Requirements : 

Qualification: M.Pharma/M.Sc/PG (Chemistry)

Experience: 10 - 12 years of work experience, at least 2 years in Managerial position

- Preferred Age Group: 35 -38 years

- Must have experience in Tablet, liquid / Oral - Tonics

- Candidate from Pharmaceutical and Cosmetic industry can apply

- 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

- Behavioural Competencies : Strong leadership with ability to manage and develop team

Key Responsibilities :

- 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.