CASY-MSCCN Jobs

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.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.