**Position:** DGM **Job Title:** Validation **Job Grade:** G8 **Function:** Projects & Engineering **Sub-function:** **Managers Job Title:** Sr.GM **Skip Level Managers Title:** **Function Head Title:** Anup Kulkarni **Location:** SunHouse -Mumbai **No. of Direct Reports (if any)** 1 **Areas of Responsibility** 1. To centrally organize, guide, control the qualification and validation programmed of each site. 2. Plan for improvement in line with best industrial, cGMP and regulatory requirement. 3. To guide the site team. (Sterile & OSD sites) 4. To Install, Qualify, Train and Implement the Qualification related software (EQVLMS) 5. Support the overseas project in conceptualization of Lay out, Contamination control strategy, clean utility qualification strategy, Equipment & Facility qualification strategy 6. Support the site team in Ergonomic study of RABS & ISOLATORS 7. Support the site team in evaluating the skid design 8. Support Project team for identification of IOT requirements for manufacturing equipment for Preventive and Predictive maintenance 9. Identify the Training needs of Qualification personnel across the sites 10. Training of Qualification team on latest trends in Qualification of Clean utilities, Facility, Equipment and Soft ware 11. Review of Qualification related GSOPs & GQS 12. Participate in recruitment process of Qualification personnel at site 13. 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 with in stipulated time lines 8) Guidance & Trouble shooting 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 Estimate** As and when required **Job Scope** **Internal Interactions (within the organization)** OK **External Interactions (outside the organization)** OK **Geographical Scope** **Financial Accountability (cost/revenue with exclusive authority)** **Job Requirements** **Educational Qualification** Bachelors in Pharmacy / Validation expert **Specific Certification** Masters in Pharmacy **Skills** **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)._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.