Unison Pharmaceuticals – Urgent Openings for Regulatory Affairs / Quality Control – Apply Now

Unison Pharmaceuticals – Urgent Openings for Regulatory Affairs / Quality Control – Apply Now

Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and most affordable medicines across the nation. With more than 4 decades of medical service to the society, Unison is today one of the fastest growing company in Gujarat State. The base of operation being a single state, the company has very strong footing in the market. In addition to this, the company is ranked 80 among top companies of India (Rupee wise sales) MAT March 2018. This makes Unison a distinguished company across the pharma industry.

Opening For Regulatory Affairs – Europe

A fast growing global company, following vacancies for the position of Asst. Manager / Dy. Manager

Key Accountabilities/ Responsibilities:

  1. During product development stage
  • Development documents review and feedback for F&D and ADL Product development plan, QBD approach, Product development report and Technology Transfer.
  • Review of API vendor documents with respect to regulatory requirements including DMF, CEP, GMP certification etc.
  1. Post TTD
  • Review of plant documents like; Stability protocol and report, Validation protocol and report, BMR and BPR, Certificate of Analysis and Sampling plan.
  1. Dossier preparation and submission
  • Collecting submission documents as per regulatory requirements (Module 2-5).
  • Compilation of dossier.
  • eCTD publishing.
  • Submission- Australia, South Africa, New Zealand and Canada and CESP- Central European Submission Portal.
  1. Post submission and product approval
  • Query response.
  • National phase.
  • Approval.
  1. Variation filing (Notification / Minor / Major)
  • Guideline assessment for variation.
  • Review of variation application according to regulatory requirement.
  • Filing of application to partner.
  • Verification of approval inline with the application.
  • Ensure revision of all related documents at plant and F&D level.

Candidates should also have sound knowledge of documentation and must be familiar with regulatory requirements.

Interested candidates may also email their resume to career@unisonpharmaceuticals.com

Opening for Quality Control – HPLC

A fast growing global company, following vacancies for the position of Officer / Sr. Officer / Executive

Key Accountabilities/ Responsibilities:

  1. HPLC Operation (Analyst)- Assay
  • Collect worksheet and sample for analysis as per plan
  • Check the instrument calibration details
  • Purging the interior part of the instrument
  • Take the columns as per worksheet and put in instrument
  • Initiate solution preparation for analysis as per worksheet which majorly includes; Mobile Phase, Standard and sample
  • Prepare HPLC sequence for analysis and get it review by reviewer
  • As per the sequence initiate the analysis and online verify SSC criteria as per worksheet
  • Post completion of the analysis perform documentation and send to reviewer
  • Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range
  1. HPLC Operation (Analyst)- Dissolution
  • Collect worksheet and sample for analysis as per plan
  • Check the instrument calibration details
  • Purging the interior part of the instrument
  • Take the columns as per worksheet and put in instrument
  • Initiate dissolution solution preparation for analysis as per worksheet and also prepare dissolution medium
  • Perform dissolution analysis as per the criteria mentioned in worksheet
  • Post completion of the analysis perform documentation and send to reviewer
  • Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range

 

  1. HPLC Operation (Analyst)- Others
  • RM- Assay, RS, IR
  • In process- Assay by UV and HPLC
  • PV Sample- Assay by UV and HPLC, Dissolution
  • FP- Assay, Dissolution, RS, DT, Average weight, hardness, Friability, IR
  • Cleaning validation

Candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.

Interested candidates may also email their resume to career@unisonpharmaceuticals.com

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