- Preparation and review of Standard Operating Procedures
- To review the vendor qualification documents and ensure the compliance in line with the SOP.
- Follow up for the vendor Qualification activities.
- To review Technology transfer documents.
- To ensure that approved vendor list is updated as per the Vendor Qualification SOP
- Review and execution Equipment, Utility, and other Qualification activities.
- Issuance and review of Batch Production and Control Records, Batch Cleaning Records, formats, Registers, Standard Operating procedures, Analytical Records and other documents.
- Review of master and executed batch production control records, Batch cleaning record and analytical documents.
- Preparation and review of Quality risk assessment records and maintain the tracking for the same.
- Preparation and review of Annual Product Quality Review.
Skills Required
- Experience in preparation and review of Standard Operating Procedures
- Knowledge of vendor qualification processes
- Familiarity with Quality risk assessment records
- Experience with Batch Production and Control Records
- Ability to conduct Annual Product Quality Review
What We Do
Established in 1988, Hikal is a reliable partner to companies in the Pharmaceutical, Animal Health, Biotech, Crop Protection and Specialty Chemical industries. We manufacture and supply quality Active Ingredients, Intermediates, Biocides to the global life sciences industry. Hikal has five manufacturing facilities in India at Maharashtra (Taloja and Mahad), Gujarat (Panoli) and Bengaluru (Jigani) and a world-class Research & Technology centre at Pune. Our facilities have been inspected and certified by the respective Global Regulatory Authorities. We create and deliver sustainable solutions for our partners and customers across the life-sciences value chain. Hikal is the partner of choice for: • Pharmaceuticals (Human & Animal Health) APIs, Generics, Custom Manufacturing, Intermediates and Advanced Intermediates • Crop Protection & Specialty Chemicals Active Ingredients, Advanced Intermediates, Intermediates • Research & Technology Process Development, New Product Development, Contract & Custom Development Hikal is the first Indian life-sciences company to receive the Responsible Care® certification governed by the International Council of Chemical Associations (ICCA).
