1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
4.00 LPA TO 5.00 LPA
Position: RA Executive
Location: Daman
Experience: 2 - 3 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, ...
1 Opening(s)
1.0 Year(s) To 5.0 Year(s)
1.80 LPA TO 4.20 LPA
Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
Technical documents like Raw Material and finished products specification, manufacturing process,
Product development report, stability reports, process validations preparation & review.
Analytical method validation review as per the ICH guideline.
Drug Master File review
Technical query response to the ...
1 Opening(s)
4.0 Year(s) To 6.0 Year(s)
5.00 LPA TO 7.00 LPA
Quality Assurance Specialist Responsibilities:
Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS).
Conduct internal quality audits and participate in management review meetings.
Handle investigations of complaints and implement corrective and preventive actions.
Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Keep in touch with international legislation, guidelines and customer practices
Keep up to the date with a company’s product range
Ensure that a company’s products comply with the current regulations.
Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
12.00 LPA TO 18.00 LPA
Job Description
Heading the regulatory department of the company and leading a team of executives/Senior executives/Asst.Manager.- Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing,guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of thedepartment.- Coordination with ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
1. Well acquainted with latest ISO 13485:2016 , CE & CDSCO norms forMedical Devices all class ( Preferably cardiac)2. Having experience of preparing dossiers for varieties of countries andtheir rules and regulations.3. Must have experience of handling ISO , CE & CDSCO audits.4. Experience of ...