Senior Manager - Production (Pharma- Sterile Products)

Pharma Jobs India
  • Baddi
  • Confidential
  • 12-17 years
  • 374 Views
  • 05 Aug 2015
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  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Experience : 12-15 yrs. years of experience in Pharma industry with exposure to Best-in-class quality systems and processes

-Should be experience in sterile plants

- Should have faced multiple USFDA / MHRA Audits

Job Description: -

- Responsible for entire manufacturing and packing operations of Ophthalmic and Respiratory Products .

- Exposure of machines like FORM Fill & Seal ( FFS), Three Piece Filling Line (Bosch), Labelling machine, Shrink packing machine, high speed cartonating

machine, and Steam Sterilizer (Fedegari).

> Preparation of monthly WIP, MIS and Machine reports.

> Monthly and weekly production planning in coordination with other departments.

> Ensuring online documentation of BMRs and BPR records complying with SOPs and regulatory requirements (USFDA / MHRA / TGA / MCC / WHO )

> Conducting Training programmes of Plant Operators and Officers on SOPs, cGMP and Guidelines.

> Proficient with Media fill, Qualification, Validation and Annual Product Review reports.

> Co-ordination with departments like QA, QC, SRC ( Regulatory), R&D, maintenance and administration.

> Validation of LAF, Steam Steriliser , and Filling machine.

> Review of master documents of BMR / BPR.

> Preparation and review of SOPs and Protocols ( Media Fill Validation , Qualification etc ).

> Successfully execution of ANDA for Three Piece / BFS

> Monthly and weekly production planning in coordination with other departments.

> Proficient with SAP system.

> Maintenance of aseptic area (Grade 'A', Grade 'B', Grade 'C') as per requirement of cGMP.

Skills

- Leadership Skills

- Team management & collaboration

- Business understanding

- Operational Excellence

- Customer satisfaction & delight

- Good Communication skills


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