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Deputy General Manager - Corporate Validation

1.00 to 4.00 Years   Mumbai (Maharashtra)   21 Mar, 2025
sun pharmaceutical ltd.
Job LocationMumbai (Maharashtra)
EducationAny Graduate
SalaryAs per Industry Standards
IndustryOthers - other Industry
Functional AreaProduction/Manufacturing/Maintenance/Packaging
EmploymentTypeFull-time

Job Description

Position:DGMJob Title:ValidationJob Grade:G8Function:Projects & EngineeringSub-function:Managers Job Title:Sr.GMSkip Level Managers Title:Function Head Title:Anup KulkarniLocation:SunHouse - MumbaiNo. of Direct Reports (if any):1Areas of Responsibility

  • 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 Software
  • Review of Qualification related GSOPs & GQS
  • Participate in recruitment process of Qualification personnel at site
  • Central point of coordination from management for simplicity and standardization if any
  1. To identify the lapses and possible improvement in the system in line with regulatory and Industrial practice
  2. Monthly review mechanism to collectively give feedback on current status
  3. To centrally co-ordinate with each site for qualification and validation
  4. To centrally co-ordinate with other supporting functions and vendors
  5. To align each site in line with management requirement
  6. Master plan all sites Validation programme
  7. Co-ordinating the sites for effective completion of Qualification activity within stipulated time lines
  8. Guidance & troubleshooting during Qualification activity
  9. To identify the new software for Qualification activity
  10. Qualification, Training and Implementation of EQVLMS across sites
  11. Standardization & Harmonization
  12. Standardization of Equipment URS. Harmonization of Qualification Protocol, Report template & Formats
  13. Review of Regulatory audit points of OSD & NOSD sites
  14. GAP analysis: Requirements vis--vis site practices. Improvement discussion & its implementation
Travel EstimateAs and when requiredJob ScopeInternal Interactions (within the organization):OKExternal Interactions (outside the organization):OKGeographical Scope:Financial Accountability (cost/revenue with exclusive authority):Job RequirementsEducational Qualification:Bachelors in Pharmacy / Validation expertSpecific Certification:Masters in PharmacySkills:Experience:Minimum 15 yrs experience in similar field.Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).Locations: Sun House - Corporate Office

Keyskills :
qualification management training implementation regulatory compliance software development project coordination osd predictive maintenance cgmp utility dgm manufacturing

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