Vacancy for the post of Head Quality Assurance in Synapse Labs
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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