The QA Validation Specialist will adhere with the cGMP principles and perform Qualification and Validations as per approved master plan.
Key responsibilities & Accountability:
Responsible for the preparation and review of validation documentation (Protocols and Reports) and SOPs to support site validation activities.
Conducts validation activities for Process and cleaning.
Supports and monitors Media fill simulation activities.
Conducts validation activities of equipment such as Autoclave, Tunnel Sterilizer, Lyophilizer, Terminal Sterilizer, Vial washing machine, vessels CIP/SIP, filling and capping machine, etc.
Conducts validation activities of Utilities such as HVAC, Water System, Compressed Air and Nitrogen gas.
Involve in product hold time activities.
Temperature mapping studies of storage facilities.
Perform all activities in compliance with safety standards and SOPs.
Bachelor / Master degree in Science/Pharmacy/Engineering
3-5 years in pharmaceutical industry in qualification/validation sections sterile manufacturing.
Real Time Experience in the companies having GMP approval from USFDA/MHRA/TGA/ANVISA/EU authorities.
Flexible to work in all shifts and not sensitive to B-Lactams.
Strong written and verbal communication skills for English language.
Honesty & Integrity
Basic IT skills and knowledge in Microsoft office (word, excel, etc.)
Technical Documents (Protocols & Reports) writing in English.
Knowledgeable with Pharmaceutical cGMP guidelines, qualifications and validations.