Unison Pharmaceuticals Job Vacancy For Regulatory Affairs/ QC
Opening For Regulatory Affairs – Europe
Position: Asst. Manager / Dy. ManagerKey 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
Position: 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
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