Jubilant Generics Limited, Roorkee is hiring for following position for their Oral Solid Dosages formulation plant. Candidate should be having good communication skills and exposure to pharma regulatory environment.
Executive/ Sr. Executive – QC (Computer System Validation and Qualification of Laboratory instruments)
• Validation and qualification of lab equipments, systems as per GAMP 5 and USP 1058
• Validation & qualification (IQ,0Q,PQ,DQ) protocols, SOP, URS, FS, CS, Risk assessment, GXP assessment, Validation master plan, Vendor Assessment, RTM.
• Negative and positive testing as per 21 CFR part 11 and Annexure 11
• Change control, computer security policies related to server/Domain and privilege & policies of analytical application software
• To coordinate with OEM, IT, Engineering department for ensuring preventive maintenance, Calibration schedule timelines and schedule
• To ensure cGMP/GLP compliance in qualification/validation activities
Desired Candidate Profile:
• Ideal candidate should be a B. Pharma or Pharma with 4 to 7 years of experience from FDA regulated plant
• Preference will be given to candidates who are Formulations (OSD background).
Interested candidates can share their resume on email@example.com