Merck & Co. looking for Head Quality Assurance

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Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967.  The Company operates both its Pharmaceuticals and Chemicals businesses in the country.
Merck was also the first Merck Group Company to go public in the year 1981.  The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd.  Merck Specialities Pvt. Ltd., the wholly owned Indian subsidiary of Merck KGaA, was incorporated in 2005.

Post: Head Quality Assurance

Job Description:
TECHNICAL AND JOB SPECIFIC
• You are responsible for Benchmarking of the Quality Assurance & Quality Control
• You are responsible for Benchmarking of the Statutory (State FDA) compliance.
• You are responsible for the improvement of the productivity in Quality Control Laboratory.
• You are responsible for the follow-up and the control of the budget (headcount, invest, expense).
• You are responsible for distributing the results obtained in the form of Quality Metrics, Statutory metrics and Key Performance Indicators to Head, CQA, Mumbai.
• You are responsible for the modifications of the procedures following the action plans of Supplier Audits, Audits by Corporate Quality Assurance, Geneva and Standards issued by Quality management, Technical Operations, Geneva and inspections by Local FDA.
• You are required to take part in the realization of the program of internal audits.
• You are guaranteeing application of rules and health, safety, industrial hygiene and environment.
• You are responsible as system owner to the following systems-

I. QUALITY & COMPLIANCE
A] Quality Systems : You need to ensure that the requirements of operations and logistics dept are met in a constant concern of Quality and Compliance, productivity and customer service.
You will ensure a low cycle time for the materials & products analyzed in the QC laboratory by timely validation of results and incident investigations in accordance with the quality procedures.
As a system owner for Deviation raising you have the responsibility to ensure that the results of quality control tests are systematically recorded and documented according to the applicable procedure and in compliance to the standards set and deviations are documented and closed.
As a system owner for Complaints raising you have the responsibility to ensure that the timely investigations are conducted & systematically recorded in Track Wise (software used for complaint management ) and documented according to the applicable procedure and in compliance to the standards set and complaint trending and corrective actions are taken.
As a system owner for Change controls raising you have the responsibility to ensure that the proposals are systematically recorded and evaluated according to the applicable procedure and in compliance to the standards set and impact assessment is thorough.
As a system owner for Out of Specification results, you will evaluate systematically results of quality control tests. Whenever out of specification & out of trend are found, they must be documented according to established standards & deviations.

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