Will adhere with the cGMP principles and perform Qualification and Validations as per approved master plan.
Key responsibilities & Accountability
1. Preparation and review of Validation documentation (Protocols and Reports) and SOPs to support site validation activities.
2. Conducts validation activities for Process and cleaning.
3. Conducts validation activities of equipment’s such as Blenders, Granulators, Vessels, Dryers, Compression, Coating, Capsule Filling , Manufacturing Liquid Tanks , Filling Equipments etc..
4. Conducts validation activities of Utilities such as HVAC, Water System, Compressed Air and Nitrogen gas.
5. Involve in product hold time activities.
6. Participation in Internal and Regulatory audits.
7. Perform all activities in compliance with safety standards and SOPs.
8. Temperature mapping Studies of Storage facilities.
- Education Bachelor/Master degree in Science/Pharmacy/Engineering
- Experience Minimum 3 years in pharmaceutical industry in qualification/validation sections Non 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
Key Competencies: Strong written and verbal communication skills for English language. Basic IT skills and knowledge in Microsoft office (word, excel, etc.) Honesty & Integrity Self-confident.
Technical Documents (Protocols & Reports) Writing in English
Flexible to work in all Shifts.
Technical Competencies Knowledgeable with Pharmaceutical cGMP guidelines , Qualifications & Validations