Summary
Experience:
2 - 5 Years
Location:
Pune
Compensation:
As per industry standard
Education:
UG - B.Pharma - Pharmacy,B.Sc - Any SpecializationPG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Bio/Pharma Informatics-Associate/Scientist
Functional Area:
Healthcare, Medical, R&D
Desired Candidate Profile
• B.Sc/B.Pharm/M.Sc/M.Pharm with 2-5 years of relevant experience in CRO / Pharmaceutical Company.
Job Description
• Review of standard operating procedures.
• Provide technical and regulatory expertise in development and application of procedures, training materials, communications and/or tools.
• Prepare audit plan and conduct audits of process and systems within CRO to ensure compliance with regulatory guidelines and Standards Operating Procedures.
• Conduct of in process & retrospective audit of method validation & subject samples analysis and reports.
• Prepare audit reports and communicate audit findings from audits to department Heads.
• Provide report assessing root causes and compliance feedback with future follow-up to Head – QA.
• Coordinate the training programs with CRO staff.
Keywords: Research Associate , Bioanalytical Quality Assurance, regulatory , training, audit plan, CRO
Company Profile
Synapse Labs is a Contract Research Organization (CRO) which offers a range of services to the Pharmaceutical and Biotechnology industry. We are dedicated to quality service, with focus on reducing time and cost, We are achieving this by understanding client requirement and working close with them to match their timeline.Synapse Labs offers services in Bioavailability/Bioequivalence Studies, Clinical Research (Phase II-IV), Data Management, Biometrics as well as formulation development and much more
Contact Details
Company Name:
Synapse Labs
Website:
Executive Name:
Pradnya Uplap
Address:
Synapse Labs
Majestic Plaza Kharadi Pune
PUNE,Maharashtra,India 411006
Majestic Plaza Kharadi Pune
PUNE,Maharashtra,India 411006
Email Address:
Telephone:
91-20-27014555
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