Asst Manager QC for an API/ Bulk Drug Plant, Mahad

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

Job Profile:

  • 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.

Requirements:

  • 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 aspsol.recruitments@gmail.com with details on current CTC, expected CTC and notice period

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