About Company:
Accuprec Research Labs Pvt Ltd. is FDCA approved, NABL accredited and ISO 9001:2015 certified
CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA.
Accuprec provides all type of Pharmaceutical testing solutions to its domestic and MNC clients.
Accuprec requires below mentioned staff.
Job Details:
- Company: Accuprec Research Labs Pvt Ltd
- Role: Sr. Research Associate (RA)
- Qualification: M.Sc./M.Pharm
- experience: 5-7 years
Job Description:
- Compilation, review and preparation of ACTD/CTD documents for regulatory submission.
- Prepare COPP, FSC application for export registration.
- Prepare documentation of FDCA, CDSCO, ISO, GLP, NABL and USFDA and compliance thereof.
- Prepare and submit applications for Medical devices to CDSCO.
- Responsible for Clinical trial approval and registration -IEC, CTRI and like.
- Responsible for monthly/quarterly return filing of RS-11/Controlled substances stock maintained/consumed to statutory authorities.
- Preparation for various lab accreditation applications/proposals.
- Compile and prepare dossier of Herbal products.
- Handling query responses from regulatory authorities.
- Review of STPs and SOPs.
- Responsible to ensure all the regulatory issues are handled as per respective SOPs, investigated to identify the root cause /most probable root causes.
- Prepare change control impacted in regulatory dossier/RA dept. SOPs.
- Responsible to review documents like change control, deviation etc. which impacted in regulatory bodies.
- Coordinate with respective department for dossier preparation time to time.
- Participates in the quality Operations management to achieve effective and efficient operation and Organization goals.
Mention your ON HAND SALARY, EXPECTED CTC and NOTICE PERIOD.
Interested candidate can Send CV on career@accuprec.in
For any Quary Please Contact 90999 32105
