Sr. Executive/Asst. Manager - RA
Quality HR Services · Not specified · onsite · Posted 28d ago
Undisclosed5–8 yrsfulltimeSourced from
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About this role
Job Summary
Position: Sr. Executive/Asst. Manager - RA
Location: Daman
Experience: 5 - 8 Years
Industries: Pharma
Responsibilities - Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities
- Coordinate with various departments to collect the complete set of documents.
- Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, batch records, stability, finished product / packaging material data for the purpose of compilation of dossier.
- Review of documents required for regulatory agencies (Viz DMF, analytical reports, process validation reports, PVP, PDR, protocols stability data)
- Preparation of various pharmacological, preclinical and toxicological data based on published literature
- Submission of the notification to regulatory agency for the post approval changes.
- Preparation of SPC, package insert and labeling information.
- Review of vendor documents as a part of vendor qualification programmer and to communicate with supplier manufacturer of the API Excipients for the related vendor documents
- Preparation of template of the vendor quality Agreement and to communicate with the vendor for its final execution
- Any other work assigned by management within the scope of regulatory framework.
- Logical thinking.
- Organizing.
- Good communication.
B.Pharm/M. Pharm/B.Sc/M.Sc - Chemistry
Sourced from naukri
Skills
vendor qualificationprocess validationDossierVendor qualityanalytical reportsCompilationstpChemistryProgrammerLiteraturePharmaPackaging Material
About Quality HR Services
Quality HR Services
Recruitment
30
employees
2017
9 years old
Vapi, Gujarat
India
₹3.1L PA avg
Avg at Quality HR Services
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Quality HR Services
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