Our client is the world’s second largest Integrated manufacturer of Ephedrine and Pseudo ephedrine salts. Our client's manufacturing facility at Mahad has been audited and approved by the Australian TGA, and the US FDA.
Post: Deputy Manager / Manager Quality Control (QC)- API
Job Description:
·Planning and managing, day to day analysis of received samples. ·Ensuring on time release of received samples.
·Review of Raw material, finished product and Intermediate documents. ·Responsible for Release / Reject the In process and Intermediate products. ·Responsible to check & sign on the certificate of analysis.
·Responsible for Retention sample management.
·Preparation and review of QC documents as per cGMP requirement.
·Ensuring on time maintenance and calibrations of all QC instruments.
·Preparation of validation protocols of new instrument installed in Quality Control Laboratory.
·Handling and Investigation of OOS and OOT results.
·Handling QC Deviations and CAPA related to QC department.
·Handling of Change proposals, document preparation, and document withdrawals.
·Ensure safety policy is strictly followed by all QC employees.
·Conduct training to staff of standard operating procedures for new SOP and training according to training matrix.
·Responsible for documents, protocols, registers issuance & control.
·Preparation of purchase order, work order and issuance of the materials.
·Ensure all stability studies are performed as per schedule. ·Preparation of shift schedule and monitoring of same.
·Ensuring co-operation between all sections of QC department
Candidate Profile:
Qualification & Experience: B.Sc. / M.Sc. with 15 to 20 year exp. Should have handled audits such as USFDA, WHO-GMP, EDQM/COS, KFDA, etc.
Industry preference: Bulk Drugs / API Candidates preferred from these locations: Patalganga MIDC, Mahad, Roha, Chiplun, Taloja industrial area
Additional Information:
Experience: 15-20 years
Education: B.Sc, M.Sc
Industry Type: API/ Pharma/ Bulk Drugs
Functional Area: QC
Salary Range: 9 to 12 lacs per annum + accommodation (if required)
Location: Mahad, Maharashtra
Last Date: 6th August, 2016
If the position interests you, please email your resume at aspsol.recruitments@gmail.com with details on current ctc, expected ctc and notice period.
Posted by,
Reema Nambiar,
Aspiring-Solutions
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