Position: Manager 2 – LL Operations for US Products  & Other    Regulated Markets

 Department: DF Sourcing

 Experience: 8 -10 years of working experience in the Pharmaceutical industry.

 Location: Mumbai

Education: Preferably B. Pharm

Reporting :  Renuka Chafaner , Sr. Manager -1

Job justification:

On account of our issue at Halol , we have nearly 19 ongoing projects , several of which are likely to be commercialized from the next few months .Factoring the complexity involved in their mfg. & the significant values at stake , we request a dedicated resource who could handle the  entire US related production activities at all the LL Sites, besides handling such activities  for our other regulated markets.

 Key Responsibilities:

• Manage all aspects of production, including work-related activities and planning.
• Develop and execute production plans on a daily, monthly, and proposed date basis to meet demand and goals.

• Monitor production to ensure alignment with planning schedules plant co-ordination and productivity targets.
• Take responsibility for internal and external audits related to production processes and quality standards.
• Have knowledge of lab instruments used in production and testing.
• Oversee finish product testing and documentation (batch cards), to ensure quality standards are met.
• Establish and maintain traceability for materials and batch cycle times.
• Coordinate between various departments like commercial, Marketing, Distribution Production, QA, QC, PRC & ,R & D in the planning process to optimize operations and enhance productivity.
• Responsible for FDA Loan license application/ COPP/ Free sale Certificate / GMP Certificate.
• Ensure the all finished goods are cleared after GMP Certification from QA.
• Tracking & Submission of Narcotic documents in time to Narcotic dept.
• Ensure that various reports (RM, PM, WIP & FG Stock statements, Yield statement etc.) are prepared on monthly basis.
• To involve in Market Complaint investigation along with site QA and coordinate with support function team to identify root cause and ensure timely implementation of corrective and preventive action.
• Share Mfg. plan to LL Site every month as per RFC
• Facilitate smooth flow of RM & PM and coordinating with purchase teams
• To Create PR for HPLC column, Filters & Working STD or any other requirement for timely delivery. 

General

• Preparation of monthly reports, internal and external data base. 
• Keep abreast with key regulatory changes and market developments in designated region /country

Key Skills:

Functional: MS Office expertise (Excel), Data analysis and strategic decision making & knowledge of SAP HANA 4

Behavioral: Learning attitude, result orientation, outcome focused , people manager, team spirit.