RA Officer - #955586

• Vapi

Job Description:

Position: RA Officer

Location: Vapi

Experience: 0- 1 Year

Industries: Pharma Formulation

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.

Required Skills:

• Should have good labour management skill
• Multi Tasking
• Logical thinking
• Organizing
• Good in communication

Required Qualification: - B.Pharm/M.Pharm

Salary :- Upto 1.80 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-

Key Skills :

• Ra
• Regulatory Affair

Company Profile

one of the fastest growing and leading -ceutical companies in India, which is engaged into third party contract manufacturing of niche -ceutical formulations.

Company was established in 1996 at - city in the state of Gujarat which is located in western parts India. With more than 300 -ceutical dosage forms like tablets, capsules, dry powder for orals, liquid orals, ointment and creams, VCPPL is currently manufacturing partner for major multinational supporting more than 100 quality formulations. We operate in more than 18 countries and have more than 100 products registered across the globe. The company has earned client’s and customer’s support due to its commitment and consistency in fulfilling the needs and demands. Our small R&D capabilities include process optimization and formulation research & development.