Name and Address of Company:
Pharmaceutical Organisation
Telephone: 040-27403495

Experience: 14 – 20 Years Location: Visakhapatnam
Compensation: Rupees 10,00,000 – 18,00,000 Negotiable
Education:UG – B.Pharma – Pharmacy PG – M.Pharma – Pharmacy
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production, Maintenance, Quality

Job Description:
Same as in candidate profile.

Desired Candidate Profile:
Position Title : Head-Production
Job Responsibilities:
Responsible for production activity for Injectable section -sterile formulation- Dry Powder Injectable ( sterile Blending and Filling) catering to regulated markets.
Responsible for manufacturing and packing operations of Liquid Parenteral Facility (Annual Capacity of 60million vials and 40million ampoules), two lyophillisation facilities (Annual Capacity of 20 million Lyophilised vials )
Execution of plans as per schedule .( ANDA/ Exhibit / Commercial manufacturing )
Monitoring of yields, productivity, Budget etc.
Responsible for compliance of production activity as per current international GMP standards.
Handling Audits ( cGMP- Regulatory agencies , HSE etc)
Providing supports for regulatory filings for ANDA, DMF, Dossiers related to various country- CA, US, EU, JP
Co-ordination with internal departments such as QA, Purchase, Engineering, Planning, Product development, Regulatory with respect to project work.
Recruitment of people – Executive and Technical associates, Training of people on the sterile operations,
Should have good experience in handling USFDA Audits.
Maintenance and monitoring of cGMP within the departments to meet current requirements as per international Quality guidelines.
Responsible for Training and development of all employees of Department to meet product quality as per cGMP requirement.
Responsible for updating the systems, process, documents, product quality and productivity.
Responsible for risk analysis and impact analysis for area, processs and various systems.
Responsible for validations of machines i.e IQ, OQ and PQ for new machines and periodic routine qualification for the existing machines.
Timely and periodic Co ordination with validation department for process validation after any changes and annually.
Responsible for Review of BMR’S, validation protocols and SOP’S.
Responsible for the handling of various regulatory audits and customers audits in Injectable and lyophillisation Facilities.
Qualification : B.Pharmacy / M.Pharmacy
Experience : 14+ Years

Company Profile:
One of the leading Pharmaceutical Organisation in the World located in Vizag (Andhra Pradesh)

How to apply for above Job:
Executive Name: Bharath / Varadarajan
Email Id: polarisindia@gmail.com
Reference Id: Bharath-Head-Production
To apply for the this job, please send your CV to the above email id with the reference id or position applied for, in the subject line.

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