Job for Manager - Quality Assurance in Sentiss Pharma

Over the years Sentiss Pharma (erstwhile known Promed group) has positioned itself as the No 3 Ophthalmic Company* in Russia and has expanded its foothold in the US and European markets.
Our key competitive advantage lies in having the R&D center together with the world class manufacturing facility that has enabled us to provide end-to-end solutions from product development to marketing. Our manufacturing facility at Nalagarh (India) is EU GMP certified and TGA (Australia) approved.

Post: Manager - Quality Assurance

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Job description

To prepare and update manufacturing records in compliance with the regulatory requirements.
To review and approve in process test reports on time release of batches for further processing.
To prepare validation protocols for the manufacturing equipment and utilities in compliance with regulatory requirements.
To perform validation and qualification of the manufacturing equipment and utilities as per the schedule.
To train operations team for the aseptic operations and GMP compliance.
To conduct periodic internal reviews or audits and to ensure that compliance procedures are followed.
To ensure compliance of the approved procedures throughout the manufacturing plant.
To perform the Internal Audits as per approved schedules and follow up on the observations.
To participate in the Regulatory and Vendor Audits and follow up on the observations.
To manage documentation control department for on time updates and changes of the procedures as needed.
To actively participate in the process development activities from R&D and Customers products as part of Technology Transfer process.
To review and approve technology transfer documentation.
To remain updated on regulations, trends and new developments related to the production and/or control of pharmaceutical products. To conduct regular communication on compliance at the manufacturing location.
To coordinate compliance monitoring activities in the plant.
To develop risk assessments and review compliance of risk areas to determine need for improvement in consultation with Production department.
To prepare reports of compliance activities and metrics.
To develop and maintain documentation of all compliance activities and communicate requirements of regulatory compliance.
To monitor and prepare detailed reports on compliance activities.
To prepare and update management on Compliance status at the plant.
To review and approve the manufacturing records for the on time release of product batches for distribution.

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TEAM MANAGEMENT
To guide and mentor the associates.
To review their performance on regular basis and provide feedback for improvement.

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Candidate Profile

The candidate should be B.Pharm / M.Pharm with 8-12 yrs of experience in Sterile Pharmaceutical company.
Candidate should have the exposure of handling the regulatory audits
Good communication skills
Interpersonal skills

Additional Information:
Experience: 8-12 years
Location: Gurgaon
Education: B.Pharm, M.Pharm
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: QA
End Date: 20^th Jan, 2014

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