Quality Assurance Associate
Boston Metro Area, Massachusetts
Under the supervision of the PV QTC QC/QA Head the incumbent participates in activities ensuring suitability of the GPE quality system by performing quality assessment on the content of data/output and key Pharmacovigilance activities.
1. Participate to the GPE Quality continuous improvement and Operational excellence programs, tracks added value and success of such initiatives.
2. Perform quality assessment of PV activities pre identified in the quality plan, in measuring compliance to process, process effectiveness and data quality:
The selection of the process and data/outputs to be reviewed by a Quality & Process specialist might be driven by his/her background knowledge/workload.
3. Investigate issues, identify the root cause and propose Corrective Action Plan Activities (CAPA); participate in CAPA implementation, Ensure monitoring activities to measure effectiveness.
4. Detect processes at risk requiring further quality assessments in Pharmacovigilance network.
5. Interact with CMQ&O auditors, GPE PV Affiliates Relations group to provide input on audit/visit action in affiliates PV units, other functions
6. Interact with any GPE units involved in the concerned reviewed activity and generating data/outputs to discuss findings and propose consistent corrective action plan.
7. Interact with USer Support group to provide input or receive feedback on findings.
8. Provide input to Standards specialists or managers and Training group to ensure appropriate SOP/training as part of corrective action plan
Candidates should have 1-4 years of work experience.
Pharmacoviligence experience is a must.
Excellent communication skills.
Ability to multi-task and stay calm under pressure.