Candidate Profile:
Education :
* Masters Degree in Chemistry, Pharmacy, Biology, or related Science or discipline.
Language:
* Fluent English required with excellent communication and negotiation skills (oral and written). Business working knowledge of another language is a plus.
Experience:
* 10-15 year’s relevant leadership experience in a regulated
Pharmaceutical industry including Quality Assurance, Quality Control,
R&D and/or Drug Regulatory Affairs.
* Experience of the manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements. Experience of managing QA at Third Party Manufacturing operations a must.
* Shows insight and good judgement in assessing complex or uncertain alternatives, including the risks of each. Considers impact of decisions on other part of the organization before making them and proposing a solution.
* Proven evidence of Systematic Problem Solving Skills including mastery of tools & skills required to handle QA remediation initiatives (FMEA, brainstorming, Fishbone, Root Cause Analysis or equivalent)
* Expert knowledge of Quality Systems with strong technical understanding and hands on experience of the pharmaceutical production (facilities, utilities, equipment, production processes, validation and laboratory controls).
* Champions Novartis Values; especially quality and customer focus, leadership, flexibility to re-organise own use of time to face emergencies in the organisation.
* Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, & Visio) with demonstrated skills in the use of information management systems in a GxP environment (Trackwise, LIMS, SAP).
* Experience in working in an international and multidisciplinary environment.
* Willingness to travel internationally; sometimes at short notice
Travel time: 20-30 %.
* Experience of the manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements. Experience of managing QA at Third Party Manufacturing operations a must.
* Shows insight and good judgement in assessing complex or uncertain alternatives, including the risks of each. Considers impact of decisions on other part of the organization before making them and proposing a solution.
* Proven evidence of Systematic Problem Solving Skills including mastery of tools & skills required to handle QA remediation initiatives (FMEA, brainstorming, Fishbone, Root Cause Analysis or equivalent)
* Expert knowledge of Quality Systems with strong technical understanding and hands on experience of the pharmaceutical production (facilities, utilities, equipment, production processes, validation and laboratory controls).
* Champions Novartis Values; especially quality and customer focus, leadership, flexibility to re-organise own use of time to face emergencies in the organisation.
* Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, & Visio) with demonstrated skills in the use of information management systems in a GxP environment (Trackwise, LIMS, SAP).
* Experience in working in an international and multidisciplinary environment.
* Willingness to travel internationally; sometimes at short notice
Travel time: 20-30 %.
Additional Information:
Job ID: 102771BR
Experience: 10-15
Location: Thane
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production
End Date: 25th June, 2013
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