Job Description

Division

IPD

Department

IPD

Employment Type

Permanent

Job Purpose

Execute the implementation of RA data system in Regulatory Affairs department for effective document and workflow managementExecute the implementation of ELN in IPD for effective information management for simplification and improvement of throughput with compliance

Accountabilities

I. Collate and document the techno commercial comparison of available new technology systems for further evaluation and decision making by the Group Leader
II. Gather user requirements and prepare a document to comply with Computerized System Validation SOP and guidelines.
III. Collaborate with the External vendors to design the system and further validation activities
IV. Create Standard Operating Procedure for the new system and conduct training for implementation in the concerned function
V. Collate and facilitate legacy data migration to the new system and perform migration validation for implementation and smooth functioning of the system
VI. Support the end user during production phase and by resolving queries during its operation and carry out system retirement for smooth integration of the new system into the existing one

Education Qualification

B.Pharm., M.Sc.(FOR ELN)

Relevant Work Experience

\xc3\xa2\xc2\x80\xc2\xa2 Minimum 5 to 10 years\xc3\xa2\xc2\x80\xc2\x99 experience in functional knowledge (Analytical, Regulatory Affairs etc.)\xc3\xa2\xc2\x80\xc2\xa2 Minimum 2 to 5 years CSV experience in Pharmaceutical Industry

Competencies/Skills

Communication Skills (clarity of thought, comprehension)

Likely potential for growth

Job / Product / Technical Knowledge / Pharma domain knowledge

Presentation & Interpersonal skills (If applicable)

Managerial or People Management skills

Safety awareness (If applicable)

Relevance of Previous Experience

Comprehension, Analytical & Problem solving abilities

Productivity & Result Orientation (If applicable)

Attitude

Qualification fitment

Sales drive (If applicable)

Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)

Job Location

Vikhroli

Shift Hours

Cipla