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Qc Manager

9-14 years

Ahmedabad

1 vacancy

Qc Manager

Intas Pharmaceuticals

posted 7d ago

Job Description

Role & responsibilities

  • Daily Planning, Execution and tracking of the batch release like DS, DP, IPQC & Protocol samples in quality control department.
  • Review and closure of all applicable QMS documents, Change Control, CAPA, Incident, Deviations, OOS, OOT and compliance investigations.
  • To Manage & responsible for Planning for analysis and tracking of batches release DS, DP, IPQC & Protocol based samples.
  • Should have strong knowledge on operational of the instrument like RT PCR, HCP, HCD, SDS PAGE, WBT, IEF, CZE, and Maurice & Protein testing by UV Spectrophotometers in Quality Control Department.
  • To prepare, review and approve the documents like SOP, STP, Specification, Protocol, MVP, MVR, DRS, and MOA, Log book, deviation, change control, CAPA, Excel sheet validation. COA and other GMP documents.
  •  To be involved at the time of LIR, OOS, OOT and investigation studies, Change Control, CAPA, Deviation, method transfer / validation activities, as and when required.
  • To manage the internal as well as external audit and Lab compliance activity.
  •  Execution of gap analysis of QC system and effective implementation of cGMP and regulatory requirements.
  • Preparation, review and revision of documents as and when required. To verify calibration/ verification/ qualification/ cleaning/ monitoring activities of various QC instruments/ equipments as per schedule.
  • To manage and review of the documents like: Method Transfer, Method Validation and responsible for the tracking of the activity till completion of the project.
  •  To provide direction to the subordinates in the labs and ensure defined quality system / GMP norms are being followed during analysis and ensure state of compliance in laboratory.
  • Responsible for general work place cleanliness, proper equipment management and adherence to all approved SOPs and GMP procedures.
  • Responsible for timeline completion and resolution of regulatory, CFT, Client, RTD query and responses.
  • Responsible for batch release in SAP and LIMS and approval of chemical reagent in LIMS. Also results to be updated in SAP.
  • Responsible for review of the logbooks, Data recording sheet, STP, Specifications, instrument labels, and pipettes calibration data.
  • Responsible for cleaning of the refrigerator and samples discarding/Antibody discarding time to time.
  • Candidates should have strong communication skill in English.


Employment Type: Full Time, Permanent

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What people at Intas Pharmaceuticals are saying

3.7
 Rating based on 3 QC Manager reviews

Likes

Good place for working, one can manage work life balance easily.

  • Salary - Good
  • +2 more
Dislikes

Office politics

  • Skill development - Poor
  • +1 more
Read 3 QC Manager reviews

QC Manager salary at Intas Pharmaceuticals

reported by 13 employees with 10-18 years exp.
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₹13.8 L/yr - ₹23 L/yr
33% more than the average QC Manager Salary in India
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