Job Description

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

• 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 * 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

• To work in coordination with Team members and CFT to resolve issues.
• Evaluation of OOS/OOT data
• 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).
• Function as EDMS coordinator
• 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
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).