Require DGM/Sr. Manager – Quality Assurance/ Quality Control in Rusan Pharma

Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by March 2009 – 150 Crs.

Post: DGM/Sr. Manager – Quality Assurance/ Quality Control

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Job Description:
10 - 15 yrs of exp in Documentation,Validation & Qualification, Internal & External Audit, handling Customer Complaints and indepth knowledge of Regulatory requirements.Well conversant with routine QA & RA activities.
Key role in developing and approving the new vendors for various materials.
Responsible for managing QA activities such as deviation management, change management, SOP compliance, batch release, supplier quality assurance, complaint handling and document review.
Responsible for preparation / review of various protocols and reports such as cleaning validation, process validation, validation master plan, computerized system validation, etc.
Managing QA activities for introduction of new product.
Communication with international corporate colleagues on various subjects.
Preparing monthly and yearly reports with respect to QA activities and presenting the same to corporate QA.
Hosting external / regulatory Quality audits.
Writing the Annual Product Review Reports.
Responsible for preparation of QA system SOPs.
Training the production and other staff for QA system SOPs.
Implementation of document management system.
Responsible for handling of customer complaints and replying to the complainant.
Responsible for preparation of the site qualification and validation master plan for current year and tracking the progress plan on quarterly basis.
Coordination for external GMP Training activity.
Preparation and Implementation of internal audit program.
10 - 15 yrs. of exp in handling Quality control functions & have indepth knowledge of Instrumental & Chemical analysis, Stability studies, analytical method validation, Cleaning validation & knowledge of Microbiological testing.

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Candidate with administrative skills along with technical expertise will be preferred.
* Define procedures for Regulatory Compliance and put in place systems for implementation.
* Fulfill requirements of licenses for state FDAs, and DCGI, obtain certificates required by marketing and DRA departments, obtain and maintain quality certification from WHO/GMP.
* Statistical performance measurement and assessment of vendors to conform quality of material as per standards acquired.
* Headcount justification with expertise and staffing for streamlining of quality function and service level excellence.
* Support to process development and R&D for tech transfer, documentation, data submission and justification for process steps in plant scale-up activities.
* Coordination with FR&D, AR&D, regulatory and marketing for smooth transfer and launch of new products.
* Handling of routine work administration and training of subordinates on critical aspects of SOPs related to sampling, documentation and analysis.
* Guidance to developing systems related to Calibrations, Qualifications and Validations of analytical instruments such as pH meter, DT Apparatus, Dissolution Apparatus, Refractometer, Polarimeter, Bulk density apparatus, TLC, conductivity meter and sophisticated instruments like UV-VIS spectrophotometer, Gas Chromatography, HPLC and FTIR.

Additional Information:
Experience: 10-15 Years
Location: Gandhidham, Ahmedabad
Education: B.Pharm / M.Pharm; B.Sc / M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, QC
End Date: 5th Jan, 2012