Executive

List of Responsibilities / Job function:

• To work as per cGMP and ensure its compliance as per current guideline and SOPs.

• Responsible to take training before execution of allotted work & maintaining the training file.

• Responsible to follow safety precaution as per laboratory procedure.

• Responsible to escalate any issue / incident to reporting manager for prompt corrective action.

• Responsible for method development studies of Drug Product & In process material

Responsible for method Validation studies of Drug Product & In process Material.

• Responsible for stability studies of Drug Product & In process Material. Responsible to align with organization goal.

• Other responsibilities assigned by reporting authority.

• Responsible to follow Quality Management Document procedure.

• Responsible to perform the calibration of instrument

• Responsible to prepare Study Protocol and Study Reports.

• Responsible to maintain instrument/equipment as per SOPs.

• Responsible for timely archival of documents as per SOP.

• Responsible to follow safety precaution as per laboratory procedure. Responsible to ensure proper Handling and Disposal of waste.

• Responsible to qualification reference standard / working standard/chemical reference standard samples as per approved and valid procedure.

• In absence of Margi a designee with equivalent of higher experience in respective area or Subject matter expert can perform the task.

List of Competencies Required:

Technical Competencies:

• M. Pharm (Pharmaceutical Quality Assurance)

• Instrumentation Knowledge HPLC/Dissolution Apparatus/Balance/pH meter, etc.

• Good Analytical & Documentation Skill

• Technical & Conceptual skill

• Creativity and Innovation

• Basic knowledge of MS office (Word, Excel & Power point)

Behavioral Competencies / Soft Skills:

• Effective communication skill

• Flexibility

• Empathetic, Integrity & Time management

• Listening skills

• Learning from others