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Hiring Compliance Manager or QA manager with extensive experience in Clinical research and managing the entire compliance/QA department of CRO or Pharma

*At least 4 to 5 years’ experience in a similar role in a Clinical Research Organization or Pharmaceutical business.
*Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
*Knowledge of maintaining and improving quality systems and procedures.
*Prior experience in a Quality role with knowledge of performing Quality checks or audits of data.
*Exposure to client audits and regulatory inspections, ideally in a Quality role.
*A demonstrated commitment to quality in a regulated environment.
*Ability to work independently, with minimal supervision, and be confident to make decisions and escalate accordingly.
*Exceptional customer services skills to both internal and external stakeholders.
*Proven clinical trials project management experience
*Life science or other relevant degree

You can share resume with divya@tech-observer.com

#hiring #clinicaltrials #clinicalresearch #pharmaceutical #compliance #qa #qualityassurance #QMS #capa #audits #CRO #clinicalresearchorganization #GCP

We are looking for QA executive with 4-5 years of experience in Vaccine QA.

Qualification- M.Sc. biotechnology/B Pharma

#qualityassurance #investigation #CAPA #Reviewer

Job Description

1. To prepare and review master documents. (i.e. Site master file, Quality Manual, SOPs)
2. To log, evaluate and review investigation and closing of Deviations/Change Controls/CAPAs.
3. To participate in Market Complaint investigation. Review the investigation and response prepared.
4. Responsible and coordination for Product recall and Mock recall committee and compile the reports.
5. To prepare Annual Product Quality Review of the products and ensure compliance to SOP & regulatory requirements.
6. To ensure storage, maintenance and destruction of the Control Samples and periodic review.
7. To prepare and review trend analysis of QMS system with cause identified and recommend measures for reducing of reoccurrence.
8. To support & review required documents for filing by regulatory affairs team.
9. To impart QMS training
10. To prepare compliance index
11. To initiate alert notification to regulatory agency and critical quality event notification to management.
12. To handle QMS software like TrackWise, Documentum, LIMS, SAP, AmpleLogic.

Send your CV at rachana.narayan@zyduscadila.com