We have an urgent requirement for the post of Manager QC (API) for a reputed API/Bulk Drug Mfg. Co. Please find the details below:
Company Name: Leading manufacturer of API bulk drugs & intermediates
Company Profile: Our client, established in the year 1986, 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
Job Location: Mahad, Maharashtra
Position : Quality Control Manager
Education: M.Sc Chemistry
Industry: API/ Pharma/ Bulk Drugs
Exp: 12-15 years experience in QC department of USFDA approved API plant
Key Skills: QC manager, API, MSc chemistry, mahad, raigad, CAPA, OOT, OOS
· 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 / 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.
· Should be conversant with management of QC electronic data to ensure compliance to CFR part 11 and current regulatory/customer expectations
- MSc. Chemistry Candidates Only
- Min. 12-15 yrs experience in QC-API Mfg Co. handling all QC activities.
- Present designation should be Asst. Manager/Manager/ Head QC with an API/ Bulk Mfg Co.
- Should be ready to relocate to Mahad.
- Good communication skills mandatory
CTC: Rs. 12-16 lacs per annum
Please email your CV on aspsol.recruitments[at]gmail.com with details on Current CTC, Expected CTC and Notice Period