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Opening for Manager-Quality Control in Rubicon Research

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Rubicon Research is a pioneer Drug Delivery Technology company in India and is recognized as a world class outsourcing partner in pharmaceutical industry. Rubicon’s proprietary technologies provide solutions for bioavailability enhancement, gastric retention, taste masking, and customising the release profiles. Rubicon has demonstrated excellence in the development of alternate dosage forms such as orally disintegrating tablets, dispersible tablets and various paediatric dosage forms.

USFDA/MHRA approved (Formulation) Pharmaceutical company based at Ambernath near to Mumbai.

Post: Manager-Quality Control department

Job Description:
* Control of Drug substance, excipients, packaging materials and drug product according to laid down specifications
* Establishing data integrity at all levels of working
* Review of Documents (Analytical work records, calibration records, log books, working standards protocols, COA's)
* Method Transfers and Method Validation
* Stability Testing and Management
* Review of Pharmacopoeial, vendor specifications,
* Reviewing Document for regulatory submissions
* Handling of Deviations, Investigations, change control, Incident Management, Risk Assessment & CAPA
* Implementation of Calibration / Preventive Maintenance of the analytical instruments
* Preparation, review of training plan
* Productivity monitoring and improvement planning.
* Handling instruments HPLC, GC etc

Candidate Profile
* Effective Communication Skills
* Good understanding of chemistry and analytical techniques
* Ability to plan the laboratory work
* Ability to guide and direct people for accurate technical deliverables
* Understanding of regulatory guidelines
* Exposure to handle USFDA. MHRA audits and only formulation dosage forms (Tablet and Capsules only)
* Should be handling team of at least 5-6 members.

Additional Information:
8-15 years
, Mumbai
"Industry Type: Pharmaceutical(Formulation)
End Date: 10th January, 2015

Send your CV to

Posted by,
Machhindra Tuwar
Rubicon Research Pvt.Ltd.

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