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Tuesday, September 14, 2010

Quality Assurance Manager Novartis

DesignationQuality Assurance Manager
Job DescriptionMaintain a basic quality systerm for the site (including training and documentation).

Advice line functions with regard to qualification of equipment and premises.

Assure that the lifecycle of equipment and premises, including computerized systems, as well as facilities related to the storage and analysis of clinical material comply with internal guidelines, SOPs, and state of the art international standards - from planning till retirement.

Assure that the corresponding requirements are appropriately implemented and followed.

Approve qualifiaction and equipment validation documentation (from plan to report, including deviation management and change control) for premises/facilities and equipment, incluting IT systems.

Carry out internal audits as well as vendor/supplier audits.
Desired ProfilePost graduate in Life Sciences / Chemistry / Biochemistry / Biochemical engineering.

Minimum 8 years experience in pharmaceutical QA/QC, with at least 5 years in a GMP analytical laboratory.

Excellent knowledge of cGMP requirements, with experience in the field of qualification of equipment and premises /facilities.

Auditing experience if possible.

Excellent english knowledge (oral and written).

Ability to interpret data and draw appropriate conclusions.

Effective team player, able to work in a flexible, dynamic working environment.
Experience8 - 13 Years
Industry TypePharma/ Biotech/Clinical Research
RoleAnalytical Chemistry Mgr
Functional AreaHealthcare, Medical, R&D
EducationUG - B.Pharma - Pharmacy,B.Sc - Any Specialization
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization, Bio-Chemistry, Chemistry
LocationHyderabad / Secunderabad
KeywordsQuality Assuarance,GMP lab experience,Good Communication Skills.
Novartis Healthcare Pvt Ltd 
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