Job Description:
EXECUTIVE VALIDATION (PROCESS EQUIPMENT )
The main activities will be as below:
– Writing Validation documents including User Requirement Specifications, RA, DQ, IQ, OQ
protocols for various Process equipment used in Pharmaceutical and Biopharmaceutical Industry.
– Interactions with client and vendors/ contractors
– On-site client-vendor co-ordination for validation activities execution as per GMP
– Execution of Validation Protocols at site and Validation document compilation.
– Maintaining Quality documentation & safety at site.
Candidate Profile:
– The candidate should be familiar with the above job description.
– Should be conversant with Schedule M, ISPE guidelines, cGMP. Shall aware of GAMP5, ASME BPE,
ASTM etc.
– Should be well versed in written & spoken English
– Strong interpersonal Skill.
Qualification:
– BE / B Tech (Chemical / Mechanical)
Requirements:
Degree/Diploma in Electrical/ Mechanical/Instrumentation/Chemical engineering with
min. 5+ years of experience in the pharma industry with a wide range of exposure including handling
projects, qualification, maintenance and troubleshooting
Experience: 3 to 6 Years in Commissioning, Qualification and Validation of Process Equipment and
other utilities in Pharma
Job location:
Pune, but will need to travel extensively anywhere In India & Abroad
Job Scope:
– Full time