Job as Assistant Manager - Equipment and Utility at Syngene

Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.

Post : Assistant Manager - Equipment and Utility

Job Description
He shall be responsible for qualification/ validation and re-qualification/ revalidation activities of Facility, utility, Equipment and system.
Review all validation related documents, SOPs.

KEY RESPONSIBILITIES:
Preparation and review of Equipment, Utility qualification relevant procedure and ensuring execution compliance as per approved SOP.
Responsible for Preparation of Protocols and reports inline to site specific SOP at API, Biologics and Formulation facilities.
Review of procedures, URS, impact assessment, Risk assessment, protocols & reports for qualification & validations for facility/ Area, equipment & utilities in facilities.
Coordinate the activities of qualification/ validation with the stakeholder departments, ensuring the timely completion of projects and project milestones.
Ensure QA validation oversight during FAT, commissioning /SAT and IQ,OQ & PQ as per qualification requirements & documentation.
Review of Design documents and execution of IQ, OQ and PQ activity of the new facility/product/process critical equipment along with documentation in place in time as per defined procedure.
Review of facility ,Utility related drawings/layouts (for ex., pressure differential, AHU zoning, area classification, equipment layouts, piping drawings, isometric drawings etc.).
Ensure QA validation oversight during periodic validation of critical utilities such as HVAC systems water system and compressed air systems revalidations.
Technical evaluation for facility /utility ,equipment modifications.
Preparation of VMP Calendar Ensuring execution of Re-qualification activities as per VMP calendar tolerance.
Support external client audits and regulatory inspections.
Preparation of Technical write up to comply audit requirements.
Any other responsibility as assigned by Head Corporate Validation based on knowledge, experience and training.

Candidate Profile
Graduate in Pharmacy / master’s in science with minimum 6 to 10 years of working Experience in API, Biologics , Formulation facility Quality Assurance/ Validation/ External Manufacturing Facility /CRO Function.

TECHNICAL /FUNCTIONAL SKILLS:
Technical knowledge in API, Biologics and Finished dosage form.
Should have Experience in Pharmaceutical Validation system.
Along with Equipment and Utility qualification experience, Work exposure to process, cleaning validation is preferred.

Should be knowledgeable on validation guidelines as per different regulatory requirements, e.g. GAMP, ICH Q7, PICS, WHO, ISPE and US FDA guidelines, 21 CFR etc.
Can establish good Interpersonal skills with cross functional teams.

Additional Information
Qualification : B.Pharm, M.Sc
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Analytical R&D (OSD)
Req Id : 6172
End Date : 30th December, 2019