Documentation Lead - API Production

Documentation Lead (Manager 1, API Production)

Location: Panoli, Gujarat

Grade: G10

Desired Skills:

• 12-15 years of documentation work in API
• Familiar with QMS handling

Key Responsibilities:

• Production planning and scheduling (day to day basis.)
• Ensuring resources available (BMR, Raw Material Manpower etc.)
• Maintain GMP norms and trained the subordinates accordingly.
• Review the BMR, incident and change control etc. and accordingly co-ordinate with R&D.
• Co-ordination with Engg. Dept. for preventive maintenance and calibration
• Ensure to maintain the online documentation and accordingly train the subordinate.
• Close co-ordination with service dept. like QA, QC, Store, Egg, Safety etc. for
• Routing work of plant.
• Ensure create and confirm the process order and ensure to complete the daily entry in SAP HANA.
• Liaison with QC/QA/Store/Engg. Dept. for solving of trouble shooting problem.
• Constantly monitoring and improvement of product process, efficiency, services etc.
• Reporting to higher authority.
• Ensure Training to subordinate.
• Ensure Documentation work, monthly reports, data preparation, root cause analysis, incident and change control etc. (process trend analysis).
• Ensure Preparation/ Revision of BMR & related accessories and SOP.
• Procurement of consumable items.
• Actively involves the Process and cleaning validation (where applicable)
• Ensuring the maintaining of documents related to Process/ Cleaning/ House Keeping.
• Control on fresh as well as recovered solvents/ spent solvents
• Responsible for administrative work related to plant
• Co-ordination with other department for solid waste, process waste and spent solvent transfer to respective area and record maintaining.
• To maintain discipline as per company's rules and regulation.
• Other Activities entrusted from time to time
• Preparation, review and revision of SOP.
• Working as a Department Training coordinator in LMS
• Operation of electronic system like SAP HANA, Leave Portal etc.