Lowongan Kerja Quality Compliance Manager PT Merck Tbk Juni 2011
PT Merck Tbk. is a leading multinational company in the pharmaceutical and chemical business in Indonesia. Founded in 1970, PT Merck Tbk went public in 1981. The majority of the shares are held by the Merck Group, headquartered in Germany, which is the oldest pharmaceuticals and chemicals company in the world.
In pharmaceuticals, we manufacture and market well-known pharmaceutical brands such as Neurobion®, Sangobion® and Glucophage®. In the Chemicals business, Merck markets a whole range of laboratory reagents, pigments and other specialty chemicals.
To accelerate our growing business, we are looking for a result-driven, dynamic and energetic candidate to fill the vacant position as:
Quality Compliance Manager
(Jakarta Raya)
Responsibilities:
* Ensure that quality complience system (Validation, GMP Training, Internal Audit/ Self Inspection Program, Regulatory Complience, Stability Review, Annual Product Review, Change Control and Deviation System, Product Complaint, Returned Goods Handling, Recall Management, Supplier Quality Management, Quality System Review) work properly, monitored and reviewed as procedure.
* Responsible for validity of SOPs related with Quaity Complience System, ensure that all GMP SOPs at Site are valid.
* Responsible to review and approve Master Packing Work Sheet.
* Ensure timely completion of CAPAs and Action Item due to deviation, chage control, SIP and other Quality System Review.
* Ensure timely preparation of proper production & quality data for new/ current product registration (both local and export) and ensure regulatory complience.
* Ensure proper and timely qualification of materials from new vendor/ manufacturer.
* Ensure that the printed packing materials preparation performed without delay (on schedule).
* Responsible for the development of the subordinates to improve their competence and effectiveness.
Requirements:
* Candidate must possess at least a Bachelor’s Degree or Master in Pharmacy/Pharmacology.
* At least 5 year(s) of working experience as Quality Function Manager in Pharmaceutical Industry is required for this position.
* Possess knowledge on GMP Quality Systems and Current Health Authority Regulation.
* Possess knowledge on ACTD Requirements.
* Possess knowledge on Statistical Analysis, e.g. Anove, SPC.
* Possess computer skill, especially Ms. Office (Word, Exel, Power Point), Corel Draw, Adobe.
* Possess Excellent in English.
* Good Negotiation and Presentation Skills.
* Willing to travel (Indonesia and abroad).
* Willing to present at site in emergency/ critical cases (on holiday or after office hour).
If you meet the above requirements, please submit your application, CV, related supporting documents, and a recent photograph, mail to:
// opportunity@merck.co.id
Please put the code QC MGR as email subject
In pharmaceuticals, we manufacture and market well-known pharmaceutical brands such as Neurobion®, Sangobion® and Glucophage®. In the Chemicals business, Merck markets a whole range of laboratory reagents, pigments and other specialty chemicals.
To accelerate our growing business, we are looking for a result-driven, dynamic and energetic candidate to fill the vacant position as:
Quality Compliance Manager
(Jakarta Raya)
Responsibilities:
* Ensure that quality complience system (Validation, GMP Training, Internal Audit/ Self Inspection Program, Regulatory Complience, Stability Review, Annual Product Review, Change Control and Deviation System, Product Complaint, Returned Goods Handling, Recall Management, Supplier Quality Management, Quality System Review) work properly, monitored and reviewed as procedure.
* Responsible for validity of SOPs related with Quaity Complience System, ensure that all GMP SOPs at Site are valid.
* Responsible to review and approve Master Packing Work Sheet.
* Ensure timely completion of CAPAs and Action Item due to deviation, chage control, SIP and other Quality System Review.
* Ensure timely preparation of proper production & quality data for new/ current product registration (both local and export) and ensure regulatory complience.
* Ensure proper and timely qualification of materials from new vendor/ manufacturer.
* Ensure that the printed packing materials preparation performed without delay (on schedule).
* Responsible for the development of the subordinates to improve their competence and effectiveness.
Requirements:
* Candidate must possess at least a Bachelor’s Degree or Master in Pharmacy/Pharmacology.
* At least 5 year(s) of working experience as Quality Function Manager in Pharmaceutical Industry is required for this position.
* Possess knowledge on GMP Quality Systems and Current Health Authority Regulation.
* Possess knowledge on ACTD Requirements.
* Possess knowledge on Statistical Analysis, e.g. Anove, SPC.
* Possess computer skill, especially Ms. Office (Word, Exel, Power Point), Corel Draw, Adobe.
* Possess Excellent in English.
* Good Negotiation and Presentation Skills.
* Willing to travel (Indonesia and abroad).
* Willing to present at site in emergency/ critical cases (on holiday or after office hour).
If you meet the above requirements, please submit your application, CV, related supporting documents, and a recent photograph, mail to:
// opportunity@merck.co.id
Please put the code QC MGR as email subject
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