A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: QA Manager
Develop and maintain a quality system for development projects and processes to ensure compliance with GMP and Novartis Quality standards at the site
Main Accountabilities and responsibilities:
Support portfolio of development projects by providing Quality input and compliance oversight, and regulatory compliance expertise in area of responsibility.
Review and approve of analytical documentation such as stability protocols, stability reports, raw data and related documents such as training documents, monitoring data to ensure GMP compliance.
Lead and drive deviation and OOS investigation to ensure root cause analysis performed by line units compliance to company standards and scientifically sound and sufficient; and defined CAPA are appropriate and are implemented in timely manner.
Support project related activities (e.g. attend team meetings, interpret results, evaluate data for trends, and draw relevant conclusions).
Perform project audits and internal audits as required
Write GMP relevant documents in own area of responsibility (e.g, SOPs)
Support the site to be at inspection ready all the time for Regulatory Inspections.
Post 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.
Experience: Minimum 5 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Type: Full Time
Employment Type: Permanent
Job ID: 113333BR
End Date: 15th, March 2013
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