Exemed Pharmaceuticals is a young business with ambitious growth goals, We currently hold GMP certification from both the WHO and the EU. We are seeking young, enthusiastic, and ambitious professionals for the following positions in light of our planned expansion in OSDI at our Vapi facility.
Required Quality Control- Officer / Sr. Officer / Executive
Job description (JD):
- Experience: 1-5 yrs
- Qualification: Masters (Chemistry)
Candidate should have following criteria:
- Experience of 1-6years in Quality Control.
- Handling instruments like HPLC and GC-Headspace.
- Handling other analytical instruments like KF-Titrator, Auto-Titrator, pH-meter, Polarimeter, UV Spectrophotometer, Balance etc.
- Analysis of In-process monitoring, Raw material, Intermediates, Stability studies and Drug substances (API).
- Analytical method development and analytical method validation exposure.
- Calibration of analytical instruments
- Should follow GLP practices, Document preparation for Specifications, SOPs, Certificate of analysis and technical reports.
Email : firstname.lastname@example.org
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Executive / Senior Executive -Quality Assurance
- Experience: 7-12 yrs
- To Review of Equipment, Instruments qualifications activities i.e. Protocol, Report execution.
- To prepare and review of Process Validation Protocol/reports, cleaning validation protocols, reports related study.
- Engineering related Compliances and including drawing list updation.
- To prepare and review of Risk Assessment for facility and product.
- To review, issue & closure of QMS documents i.e. Change Control, Deviation, OOS, OOT, CAPA, Market complaints etc.
- To review new master BMR/ECR.
- To review APQR and PQR for MFH and Allopurinol USP, CEP and ROW and to ensure data updated regulated.
- Responsible for approve or reject intermediate & Bulk and to release finished product batches.
- Responsible for the Document archival room management.
- Responsible for Transport validation activity.
- Responsible for Documentation for FDA & WHO for renewal or new license applications.
- In charge of IPQA team (Sampling, Labeling and Control sample)
- To perform internal audit (Self inspection)/external audits and provide compliance report for internal/external audits.
- To prepare and review the SOPs as per SOP on SOP.
- To Review PTD, Technology transfer documents as per SOP for new products.
- To ensure GMP compliances in Facility.
- Responsible for initiation, compilation of activities required as per respective SOPs.
- Responsible to ensure and carry out proper document correction and writing procedure.
- To verify preventive maintenance & calibration activities performed of all equipment & measuring instruments in the manufacturing plant.
- Responsible for preparation & review of VMP & SMF.
- Responsible to verify the technical documents of manufacturing and R & D.
- Responsible for the regulatory and customer correspondence.
- To review SOPs, STPs, specifications and GTPs.
- Responsible for Stability summary report Approval.
- To Review Batch Manufacturing Records, Batch Processing Records, Equipment Cleaning Records, Process Development Reports.
- To prepared, Review and Approved COA.
- Responsible to maintain reconciliation of the product labels, Approved label and seal in the respective logs.
- Responsible for return and recall of materials and also for mock recall activities.
- Responsible for preparation of Organogram of personnel in departments.
- Responsible sampling activities as per SOP,
- To review of Method Validation Protocols & Reports.
- Responsible for the review of the stability study protocol, sample charging in stability study and withdrawal of samples, stability study report review and summary report preparation.
- Responsible for the issuance, distribution, and retrieval of SOPs and logbooks.
- Responsible for the issuance, retrieval and review of BMR, BPR, ECR, SRR and other processing documents, to provide batch numbering as per SOP.
- Responsible for the control sample management and document control activities.
- To ensure Standard Operating Procedures followed and displayed in the plant.
- To co-ordinate during finished product dispatch.
- Responsible for other activities as instructed by Head-QA whenever required.
Email : email@example.com
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Required ADL Officer / Sr. Officer – Pharma API (Vadodara)
Company Name: Exemed Pharmaceuticals
- Location: Luna/Ekalbara
- ADL Officer / Sr Officer
- Education: MSc Organic or Analytical Chemistry
- Experience: 2 to 5 years experience in API Industry only.
Candidate must have:
- Knowledge of method validation by HPLC and GC
- Knowledge of ICPMS method development and method validation Knowledge of how to review analytical documents
Interested candidate may share updates resume on firstname.lastname@example.org
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- Department:- R&D Synthesis
- Qualification:- M.Sc. (Chemistry/Organic Chemistry)
- Experience:- 1-5years of relevant experience
- Location :- Vadodara Key Skills and Competencies: -Experience in Organic Synthesis / Multi-step Synthesis.
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