We have an urgent requirement for the post of Asst. Manager-QC with our reputed client into API/Bulk Drug Mfg Co. Please find the details below:
Job Location: Mahad, Maharashtra
Reporting Structure: Deputy Manager / Manager
Experience: 8-12 yrs in API/ Bulk Drug Co.
Dept: Quality Control
CTC: Rs. 6-8 lacs per annum
- Execution of analytical and cleaning method validation including preparation of validation protocol and report
- Section incharge of GC instrumentation lab.
- Tracking calibration records and schedule for all instruments including external calibrations.
- Imparting instrument handling and analysis training to new joiners and during change of job profile.
- Preparation of SOP, new instrument SOP’s along with IQ, OQ, PQ documents.
- Preparation of validation protocols of new instrument installed in Quality control Laboratory.
- Conducting analyst Qualification of new joiners before deploying to job.
- Document issuance from QC (Raw data protocols and other related raw data), and other routine document changes and new implementation.
- Check and sign Log book, register, raw data protocols and COA’s.
- Preparation of purchase order, work order and material requisition.
- To function as a department head in absence of Manager QC and to delegate the responsibilities for Sr. Officer, Officers, Jr. Officer during his absence.
- 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.
- Review of daily temperature and Humidity record of stability chamber.
- Document checking of analysis of FP, Raw material, INT, INP & Stability samples.
- Conduct training to staff of standard operating procedures for new SOP and training according to training matrix.
- Candidate should be from Maharashtra
- Computer Knowledge: Basics, SAP will be added advantage
- Ready to relocate to Mahad, Maharashtra
If the position interests you, please email your cv at firstname.lastname@example.org with details on current CTC, expected CTC and notice period