Quality & Process Specialist

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Responsibilities:

• 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.
• Participate to the GPE Quality continuous improvement and Operational excellence programs, tracks added value and success of such initiatives.
• 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.
• Investigate issues, identify the root cause and propose Corrective Action Plan Activities (CAPA); participate in CAPA implementation, Ensure monitoring activities to measure effectiveness.
• Detect processes at risk requiring further quality assessments in Pharmacovigilance network.
• Interact with CMQ&O auditors, GPE PV Affiliates Relations group to
• provide input on audit/visit action in affiliates PV units, other functions
• Interact with any GPE units involved in the concerned reviewed activity and generating data/outputs to discuss findings and propose consistent corrective action plan.
• Interact with USer Support group to provide input or receive feed back on findings.

Requirements:

• Strong analytical skill and developed insight for analysis of issues ensuring scientific rigor/good quality in all analyses and decision-making based on sound risk-based judgment 2.Excellent writing and
• communication skills; 3. Strong interpersonal skills: interaction with individuals of various background such as various levels in other departments and other countries 4. Ability to provide clear concise summary and identify key issues which are a concern for GPE.
• Ability to work independently and successfully manages multiple priorities simultaneously.
• Ability to identify gap in quality issue and investigate to clarify root cause.
• Demonstrated ability to participate in creation of a corrective action plan and monitor its effectiveness to meet the needs ofassociates/department/unit/country/GPE
• Computer literacy (Microsoft Office).
• Good understanding of Quality Management System and their implementation
• In-depth knowledge of International Pharmacovigilance requirements,US FDA, EMEA requirements/international guidelines, ICH/CIOMS.
• Experience in Quality management: QA, audit, corrective action plan (CAPA methodology) definition and implementation, would be a plus.
• Understanding of database organization, documentations system would be a plus

Education:

• Minimum experience 5 to 7 years in International Pharmacovigilance activities including case processing, involvement in interaction with affilaites, training users
• Certified health professional degree required: example Pharmacist or Pharm
• D or Bachelor of nursing degree.
• Demonstrated Understanding of Pharmacovigilance processes, PV database system, Dictionaries required.
• Knowledge of international regulations and guidelines ICH, CIOMS, EMEA/FDA

All your information will be kept confidential according to EEO guidelines.