Job Description :
Purpose : The QA Validation Specialist - Non Sterile Dosage form will adhere with the cGMP principles and perform Qualification and Validations as per approved master plan.
Key responsibilities & Accountability : Preparation and review of Validation documentation (Protocols and Reports) and SOPs to support site validation activities.
Conducts validation activities for process and cleaning. Conducts validation activities of equipment such as Blenders, Granulators, Vessels, Dryers, Compression, Coating, Capsule Filling, Manufacturing Liquid Tanks, Filling Equipment, etc.
Conducts validation activities of Utilities such as HVAC, Water System, Compressed Air and Nitrogen gas. Involve in product hold time activities.
Participation in Internal and Regulatory audits. Performs all activities in compliance with safety standards and SOPs. Temperature mapping Studies of Storage facilities.
Qualifications : - 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. - 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.