Accuprec Research Labs Pvt Ltd. is FDCA 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
Experience : 2-8 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.'Preparation and Review of QA SOPs.
Sr. Research Associate (RA)
Qualification : M.Sc./ 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.
Research Assistant / Research Associate (RA)
Qualification : M.Sc./ M.Pharm
Experience : 0-4 years
Job Description :
Carry out work of compilation, review and preparation of ECTD documents for Regulatory Submission,COPP,FSC application for export registration, documentation pertaining to FDCA,ISO,GLP,NABL,CDSCO and USFDA etc.
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
Manager (MB)
Qualification : M.Sc./ M.Pharm
Experience : 10-15 years
Job Description :
• To supervise and manage microbiological testing, BET testing, sterility testing, bioburden, bio¬assays of antibiotics & vitamins, PET test and like, for various types of pharmaceutical products, AYUSH as well as for medical devices.
• You have to also supervise and manage cell-line and Biotechnology department involved in various kinds of in-vitro testing like cytotoxicity, genotoxicity, carcinogenicity, DNA Analysis, RNA Analysis, PCR and like.
• You have to involve yourself to carry out in-house R & D projects and to prepare and submit Detailed Project Reports (DPR) to fetch financial grant from various funding agencies of India as well as outside India.
• You have to work out for SOP preparation and maintain QMS system, as per GLP standard related to the microbiology department.
Job Location : Ahmedabad
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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