Accuprec Research Labs Hiring for QA / Regulatory Affairs / Biotechnology / Microbiology

About Us

Accuprec Research Labs Pvt. Ltd. ® has been incorporated by a group of highly qualified technical promoters. The main object of establishment of Accuprec Research Labs is to offer different facets of testing solutions at single platform for variety of Pharmaceutical and chemical products starting from their discovery phase to clinical phase

Vacancy Details

1. QA

• Role: 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞 (𝐐𝐀) / 𝐒𝐫. 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞 (𝐐𝐀)
• Qualification: 𝐌.𝐒𝐜./𝐌.𝐏𝐡𝐚𝐫𝐦
• Experience: 2-8 years

Job Description

1. Review, assessment and closing of Change control, Deviations, Out of Specification, CAPA &
   Investigation reports.
2. Participation in Internal Audits & Compliance Activity
3. Establishing & implementing quality system,
4. Co-ordinate with the cross functional department whenever required. – Preparation and Review of QA SOPs.

2. Regulatory Affairs

• Role: 𝐒𝐫. 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞 (𝐑𝐀) / Research Assistant / Research Associate
• Qualification: 𝐌.𝐒𝐜./𝐌.𝐏𝐡𝐚𝐫𝐦
• Experience: 0-8 years

Job Description

1. Compilation, review and preparation of eCTD/CTD documents for regulatory submission
2. Prepare COPP, FSC application for export registration
3. Prepare documentation of FDCA, CDSCO, ISO, GLP, NABL and USFDA and compliance thereof.
4. Prepare and submit applications for Medical devices to CDSCO.
5. Responsible for Clinical trial approval and registration -IEC, CTRI and like.
6. 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.

3. Biotechnology 

• Role: Sr. Research Associate
• Qualification: M.Sc. (Biotech) Ph.D
• Experience: 5-7 years

Job Description

1. Experience in cell and molecular biology in an industry setting
2. Strong publication record demonstrating expertise in cell and molecular biology.
3. Hands-on experience in handling PCR, RT-PCR, ELISA and relevant biotechnology instruments

4. Microbiology

• Role: Manager
• M.Sc./ M.Pharm
• Experience: 10-15 years

Job Description

1. 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.
2. 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.
3. 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
4. You have to work out for SOP preparation and maintain QMS system, as per GLP standard
   related to the microbiology department.

Interested candidates send their resumes on mail ID: career@accuprec.in

For any Inquiry, Contact : 90999 32105

Note : Candidates must have exposure of Pharma regulatory approved organisations
(USFDA, MHRA, Eu and other Major regulatory bodies)