Executive / Sr. Executive - R&D Quality

Position: Executive / Sr. Executive

Job Title: Executive / Sr. Executive

Job Grade:

Function:R&D Quality

Sub-function: CMCQA Formulation

Manager s Job Title: DGM

Skip Level Manager s Title: NA

Function Head Title: AVP

Location: Vadodara

No. of Direct Reports (if any): NA

Areas of Responsibility

1. Review of various formulation and packing development / technology transfer documents like but not limited to Master Formula, Master Formula Card, Product Development Report, Dissolution Development report, Elemental Impurity Risk Assessment Report, Stability plan, QbD based Risk Assessment report, Failure Mode Effect Analysis, Process Validation Protocol / report, Master packaging record, Study Protocol & report etc. as per internal guidance and procedures for various markets.
2. To assist in developing procedures / system and for assuring compliance to them by the R&D function by identifying GAP and bridging through document review/audit
3. To work in coordination with Team members and CFT to resolve issues.
4. Evaluation of OOS/OOT data
5. Departmental Training Coordinator in Learning Management System as per defined role like assign job to a user, add / removal of user to a job, assign learning activity to a job, to create curriculum).
6. Function as EDMS coordinator
7. Prepare departmental internal report for management information

Travel Estimate: Nil

Job Scope

Internal Interactions (within the organization)

• Various R&D and Site Functions

External Interactions (outside the organization)

• Not Applicable

Geographical Scope

• India

Financial Accountability (cost/revenue with exclusive authority)

• NA

Job Requirements

Educational Qualification

• M. Pharmacy

Specific Certification

• Six sigma or equivalent

Skills

• Technical understanding, Oral and Written Communication

Experience

• 5 to 7 years