Unison Pharmaceuticals Released Job Openings On 29-01-2022. Unison Pharmaceuticals is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics…Interested and eligible candidates can submit application along with resume.
Vacancy Details:
Unison Pharmaceuticals Recruiting Candidates with 016+years of Experience for Regulatory Affairs / Quality Control Position.Complete Details for the Regulatory Affairs / Quality Control as follows.
Important Details :
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 29-01-2022
- Mode of application :Online
- How To Apply: Interested candidates may also email their resume to career@unisonpharmaceuticals.com
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Job Description/Skills Required
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.
2. Post TTD
- Review of plant documents like; Stability protocol and report, Validation protocol and report, BMR and BPR, Certificate of Analysis and Sampling plan.
3. 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.
4. Post submission and product approval
- Query response.
- National phase.
- Approval.
5. 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
2. 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
3. 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
