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    • pune, maharashtra
    • permanent
    There is an urgent job opening in an established Company which is in the field of Contract Manufacturing & Contract R&D. Designation: Head - QA Qualification: M.Sc. Chemistry / PhD in Organic Chemistry (PhD candidate more preferred)Experience: About 15 years (At least 3 years at a level of Sr. Manager level) in  API, CRAM facility with good regulatory environment.Responsibilities Lead a team of 15-20 staff for quality compliance and Lead department in quality audits. should have experience in quality assurance & quality control. should be able to manage the team & give them the training. should be able to coordinate with different departments. must have excellent communication skills. must be able to handle the queries from audit team. To ensure efficient management of QA & QC functions.To monitor the Batch release of APIs, Intermediates, raw materials and packaging materials and ensure these are in compliance to SOPs, Specs, Regulatory/customer commitment. Encourage quality improvement programs and reduce costs of quality. To ensure compliance to GMPs in respective areas as per Quality Policy, Quality System, SOPs.Ensure timely approval of material by quality control and to enable timely dispatch of finishedproducts in accordance with statutory rules and regulations and customer requirement.Provide guidance to Training Managers and approve all cGMP/GLP training programs for technical functions. To review and approve all cGMP related documents. Review, Approved/Reject change controls related to manufacturing, QC, QA, R&D, Engineering as per SOP. To evaluate vendor as per SOP. Conduct self-inspection audits as lead auditor and ensure the compliance to cGMPrequirements. Review approve/Reject specifications, analytical methods, SOPs, Master Batch Record. To handle external audits, review the audit reports, prepare response for audit observations and ensure closure within time. To review stability study data and establish expiry or retest date. Experience in ISO management system and related audit shall be added advantage.
    There is an urgent job opening in an established Company which is in the field of Contract Manufacturing & Contract R&D. Designation: Head - QA Qualification: M.Sc. Chemistry / PhD in Organic Chemistry (PhD candidate more preferred)Experience: About 15 years (At least 3 years at a level of Sr. Manager level) in  API, CRAM facility with good regulatory environment.Responsibilities Lead a team of 15-20 staff for quality compliance and Lead department in quality audits. should have experience in quality assurance & quality control. should be able to manage the team & give them the training. should be able to coordinate with different departments. must have excellent communication skills. must be able to handle the queries from audit team. To ensure efficient management of QA & QC functions.To monitor the Batch release of APIs, Intermediates, raw materials and packaging materials and ensure these are in compliance to SOPs, Specs, Regulatory/customer commitment. Encourage quality improvement programs and reduce costs of quality. To ensure compliance to GMPs in respective areas as per Quality Policy, Quality System, SOPs.Ensure timely approval of material by quality control and to enable timely dispatch of finishedproducts in accordance with statutory rules and regulations and customer requirement.Provide guidance to Training Managers and approve all cGMP/GLP training programs for technical functions. To review and approve all cGMP related documents. Review, Approved/Reject change controls related to manufacturing, QC, QA, R&D, Engineering as per SOP. To evaluate vendor as per SOP. Conduct self-inspection audits as lead auditor and ensure the compliance to cGMPrequirements. Review approve/Reject specifications, analytical methods, SOPs, Master Batch Record. To handle external audits, review the audit reports, prepare response for audit observations and ensure closure within time. To review stability study data and establish expiry or retest date. Experience in ISO management system and related audit shall be added advantage.

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