Job Description :
Purpose : The QA Senior Specialist-Sterile Dosage Forms will adhere with the cGMP principles and perform Qualification and Validations as per approved master plan.
Key responsibilities & Accountability : Expert in Process Validation of Parenteral and Biotech Dosage forms. Expert in Cleaning Validation of Parenteral and Biotech Dosage forms.
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. Involves in product hold time activities.
Temperature mapping studies of storage facilities. Performs all activities in compliance with safety standards and SOPs.
Qualifications : - Education Bachelor / Master degree in Science / Pharmacy / Engineering - Experience : 5-7 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. - Training : Key Competencies : Flexible to work in all shifts and not sensitive to B-Lactams.
Strong written and verbal communication skills for English Language. Honesty & Integrity Self-confident. Technical Competencies : 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.