Senior Executive- CQA

2COMS Consulting Pvt. Ltd.
  • Hyderabad
  • 4-7 lakh
  • 5-8 years
  • Views
  • 05 Jan 2018

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

1.Should have experience in Quality Control and on LIMS 2.Knowledge on a) ICH guidelines b) QMS systems c) Exposure on Regulatory, FDA,MHRA, MCC etc.. d) Pharmacopoeia updates 3.Candidates should be preferable who having experience on LIMS. 4.Preparation, review and approval of Specifications for Raw materials, In- process, Finished Product and packing materials in LIMS. 5. Preparation and review of STPs for Raw Materials and Finished Product. 6.Initiation, review and approval of Validation samples, Compatibility samples, Working Standard specifications and any other specifications in LIMS. 7. Review and approval of volumetric solutions worksheets in LIMS. 8. Review and approval of Business associate, approved vendor details in LIMS. 9.To provide the approved/ updated Specifications and STPs to respective units. 10. Initiation of Change controls pertaining to Specifications and STPs. 11. Initiation of Process non conformances and CAPA implementation. 12. To coordinate and follow up with other departments FARD, RAD and respective unit QA, QC persons, for timely support and ensure the available of specifications as and when required. 13. Verification of specifications and STPs in compliance with dossiers, Product approval package (PAP) and Regulatory commitment packages/Registered product information (RPIs). 14 Responsible to verify the specifications and STPs across all formulation units for harmonization. 15.Responsible to archive the Master copies of the Standard Test Procedure. 16. Responsible to send the controlled copy of standard test procedure to respective units. 17. Responsible for sending and archive the distribution formats. 18.Responsible to make obsolete Master copy of standard testing procedure as and when required.

Competencies/Skill sets for this job

Qa Who Cqa Qc Qms Quality Control Mhra Validation Fda Quality Assurance

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About Organisation

2COMS Consulting Pvt. Ltd.