Executive / Sr. Executive - R&D Quality

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).