Overview
DGM Validation Jobs in Mumbai, Maharashtra, India at SUN PHARMA
Title: DGM Validation
Company: SUN PHARMA
Location: Mumbai, Maharashtra, India
Job Role : Validation Lead
Job Grade : DGM
Job Function : Projects & Engineering
Job Location : Mumbai
Responsibilities :
To centrally organize, guide, control the qualification and validation programmed of each site.
Plan for improvement in line with best industrial, cGMP and regulatory requirement.
To guide the site team. (Sterile & OSD sites)
To Install, Qualify, Train and Implement the Qualification related software (EQVLMS)
Support the overseas project in conceptualization of Lay out, Contamination control strategy, clean utility qualification strategy, Equipment & Facility qualification strategy
Support the site team in Ergonomic study of RABS & ISOLATORS
Support the site team in evaluating the skid design
Support Project team for identification of IOT requirements for manufacturing equipment for Preventive and Predictive maintenance
Identify the Training needs of Qualification personnel across the sites
Training of Qualification team on latest trends in Qualification of Clean utilities, Facility, Equipment and Soft ware
Review of Qualification related GSOP’s & GQS
Participate in recruitment process of Qualification personnel at site
Central point of coordination from management for simplicity and standardization if any
o identify the lapses and possible improvement in the system in line with regulatory and Industrial practice. Monthly review mechanism to collectively give feedback on current status
14) To centrally co-ordinate with each site for qualification and validation
15) To centrally co-ordinate with other supporting functions and vendors
16) To align each site in line with management requirement
17) Master plan all sites Validation programme
18) Co-ordinating the sites for effective completion of Qualification activity with in stipulated time lines
19) Guidance & Trouble shooting during Qualification activity
20) To identify the new software for Qualification activity
21) Qualification, Training and Implementation of EQVLMS across sites
22) Standardization & Harmonization
23) Standardization of Equipment URS. Harmonization of Qualification Protocol, Report template & Formats
24) Review of Regulatory audit points of OSD & NOSD sites
25) GAP analysis: Requirements vis-à -vis site practices. Improvement discussion & it’s implementation
Educational Qualification :Bachelors in Pharmacy / Validation expert
Experience Minimum : 17 yrs experience with strong experience in Validation (OSD & Sterile)
