HomeProductionSr Manager QC | Global Calcium | Hosur, TN

Sr Manager QC | Global Calcium | Hosur, TN

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As an EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979 as Calcium India. Today, Global Calcium represents the true hallmark of quality when it comes to pharmaceutical products.

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For more details visit: http://www.globalcalcium.com/

Position: Sr Manager QC

Location: Hosur, Tamil Nadu, India

Job Description:

  • Ensuring on-time testing of raw materials, in-process samples, intermediates, finished products, and stability.
  • Investigation of OOS and OOT laboratory results and documentation of such investigation, including action taken.

     

  • Review and updating of specifications for input materials, intermediates, APIs, finished products, and stability products to ensure compliance with company standards.

     

  • To ensure Validation and revalidation of analytical methods as per requirements.

     

  • Training of analysts in laboratory techniques, SOP, GLP, and GDP.

     

  • To ensure stability studies are performed on finished products and API at an appropriate frequency as per protocols and certify relevant documents.

     

  • Responsible to carry out the Food & Feed Safety activities and ensure to comply with the statutory and regulatory requirements.

     

  • Updating the analytical methods as per current pharmacopeia and regulatory requirements and ensuring compliance.

     

  • Instrument/ Equipment qualification and requalification( if necessary) as per schedule.

     

  • Support the regulatory affairs department.

     

  • To review the procedures for the microbiological testing.

     

  • To ensure the availability and compliance of chemicals, reagents, standards, and instruments in the laboratory.

     

  • Review of laboratory records.

     

  • Review and approval of analytical reports.

     

  • Review of calibration, preventive maintenance and stability schedules.

     

  • Review of vendor qualification documents and ensuring the adequacy of the documents.

     

  • Responsible for reviewing change control, deviation and CAPA pertaining to laboratory operations.

     

  • Participation and support of the internal audit.

     

  • Review of QPR.

     

  • Participation and review of qualification, validation activity, and documents.

     

  • To coordinate for external calibration activities.

     

  • Attending and participating in food safety team meetings

     

  • Reviewing of PRPs and CCP’s as per relevant procedures.

     

  • Any other assignments, given by the Quality Assurance like current Pharmacopoeia implementation and updating of the documents, special assignments, product evaluation, complaint investigation, performance evaluation of Quality Control personnel.

Qualification: MS/M.Sc – Biochemistry/Organic Chemistry

Experience: 10-20 Years

Salary: Negotiable

Contact Details:

Ezhilarasi

ezhil.m@globalcalciumpharma.com

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