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.
Post: Head Quality Assurance
Job Description:
a) Responsible for implementation and maintenance of Quality Assurance systems in the organization
b) Review & approval of Standard Operating Procedures.
c) Planning & overseeing the conduct of in-process and retrospective audits in clinical, Bioanalytical, pharmacokinetic, statistical and IT departments.
d) Planning & overseeing conduct of systems audits in the facility
e) Review & authentication of study reports.
f) Planning & overseeing conduct of vendor audits.
g) Ensuring that Bioavailability/ Bioequivalence studies are conducted in adherence with Protocol, SOPs, GCP, GLP and applicable regulatory requirements.
h) Review and approval of audit plans & audit reports prepared by a team of QA auditors for internal and external audits.
i) Coordinate the compliance activities for Client audits and Regulatory inspections.
j) Handling Regulatory Inspections
k) Train & Develop QA Staff for Auditing
Additional Information:
Experience:5-10 years
Location: Pune
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Email your resume, careers@synapselabs.com
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