Deputy General Manager - Corporate Validation

Job Summary:

Position:DGM

Job Title:Validation

Job Grade:G8

Function:Projects & Engineering

Sub-function:

Manager s Job Title:Sr.GM

Skip Level Manager s Title:

Function Head Title: Anup Kulkarni

Location:SunHouse -Mumbai

No. of Direct Reports (if any)

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 GSOP s & 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 & it s 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

• Master s in Pharmacy

Skills

Experience

Minimum 15 yrs experience in similar field.