Job for M.Pharm as Site Quality Manager at Clariant
Clariant is a globally leading specialty chemicals company, based in Muttenz near Basel/Switzerland. On 31 December 2015 the company employed a total workforce of 17 213. In the financial year 2015, Clariant recorded sales of CHF 5.807 billion for its continuing businesses. The company reports in four business areas: Care Chemicals, Catalysis, Natural Resources, and Plastics & Coatings. Clariant's corporate strategy is based on five pillars: increase profitability, reposition portfolio, add value with sustainability, foster innovation and R&D, and intensify growth.
Post : Site Quality Manager-Cuddalore
- Implement and improve the system management for ISO 9001 and ISO 15378
- Lead the risk analysis team. (lead FMEA or HACCP team) and ensure the follow up
- Ensure cGMP rules adapted to our business are implemented, respected.
- Manage documents into GMS
- Responsible for GMP and IPC training, and responsible training efficiency.
- Ensure customers requirements are well defined. Validate Customer Quality Agreements and questionnaires
- Lead customer complaints (CAPA), CAPA team
- Is independent from production (functional link with the head of Quality). Is allowed to stop production.
- Lead customer audits, and is responsible for audits follow up (CAPA)
- Lead improvements and ensure that root cause analysis methodology is well applied.
- Manage and document handling of returns and restricted materials
- Is the site management representative
- Escalate a risk of recall to upper management and the criteria for recall
- Can escalate any issue (internal or external) to the upper management (head of quality)
- Lead and coach QA/QC team
- Is responsible for people development (evaluation, training, talent identification…)
- Coordinate regulatory affairs with Product Stewardship for the plant
Candidate Profile :
M-Pharm or related
15 years experience in Quality Control & Quality Assurance in the Pharma or related Industry
Experience in the following would be an advantage : Lean Sigma methodology, 8D methodology, ISO 15378.
Well conversant with USFDA regulations
Fluent in spoken and written English
Knowledge of Tamil is a must.
Experience : 15 Years
Qualification : M.Pharm
Location : Tamilnadu - Cuddalore
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 10th March, 2017
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