Accuprec Research Labs Pvt Ltd. is F DC A approved, NAB L 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.
Research Associate / Sr. Research Associate (QA)
Qualification : M.Sc./M.Pharm with 2-7 years of experience
• Review, assessment and closing of Change control, Deviations, Out of Specification, CAPA & Investigation reports.
• Participation in Internal Audits & Compliance Activity.
• Establishing & implementing quality system.
• Co-ordinate with the cross functional department whenever required.
• Facility round and document verification.
• Review QA documentation
• Preparation and Review of QA SOPs.
• QA SOPs compliance verification.
• Conduct risk assessment, investigations as per requirement
• Responsible for timely execution of self-inspection, vendor audits, revisions of documents, regulatory audits
Sr. Research Associate (RA)
Qualification : M.Sc./M.Pharm with 5-8 years of relevant experience
• Compilation, review and preparation of eCTD/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-II/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 pertaining to RA
• 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 training to achieve effective and efficient operation and Organization goals.
Location : Ahmedabad
Mention your ON HAND SALARY, EXPECTED CTC and NOTICE PERIOD.
Interested Candidate can Send CV on email@example.com
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