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.
Sr. Research Associate (QA)
Qualification : M.Sc./ M.Pharm
Experience : 5-8 years
Job Description :
• 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.
Sr. Research Associate (RA)
Qualification : M.Pharm
Experience : 5-8 years
Job Description :
• 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.
Sr. Research Associate (Biotech)
Qualification : M.Sc. (Biotech) Ph.D. desirable
Experience : 5-7 years
Job Description :
• Experience in cell and molecular biology in an industry setting.
• Strong publication record demonstrating expertise in cell and molecular biology.
• Hands-on experience in handling PCR, RT-PCR, ELISA and relevant biotechnology instruments
Sr. Research Associate (Formulation Development)
Qualification : M.Sc./ M.Pharm
Experience : 5-8 years
Job Description :
• Development of Formulation for ANDA and other regulatory submissions
• Should possess knowledge of Patent search, QbD, DoE etc.
• Should possess experience of preparation of MFR, PDR, TT and execution of pivotal, pilot and execute batches
Assistant Manager (QAU)
Qualification : M.Pharm. (Pharmacology) / M.Sc. (Biology / Toxicology)
Experience : 8-10 years
Job Description :
• Should possess experience of QAU as per OECD-GLP guidance documents and face audit by NGCMA.
• It is desirable if faced audit by NABL, AAALAC, USFDA and like other regulatory agencies.
* Positions Open For Ahmedabad Location
Interested Candidates send their resumes on mail ID : career@accuprec.in (Mention your In-Hand Salary, Expected Salary, CTC)
Salary no bar for right candidate.
Note : Candidates must have exposure of Pharma regulatory approved organisations (USFDA, MHRA, Eu and other Major regulatory bodies)
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