Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Responsibilities:
Triage deviations/quality events; perform causeandeffectanalysis(e.g. 5 Whys Fishbone) identify true root cause(s) and draft clear testable CAPAswith owners due dates measurable outcomes and effectivenesscheck (EC) plans.
Author and review CAPAsto a publishable standard (concise problem statement containment corrective preventive verification/validation residual risk).
Steward CAPA lifecycle: tracking timely closure EC results trend recurrence and lessons learned.
Own the PV Quality Management System (QMS)controls for the project ensuring alignment to ICH EU GVP FDA MHRA and client procedures.
Design and facilitate CAPA & Compliance forumsfor OPE and delivery teams (short learning bursts case studies error prevention What good CAPA looks like).
Maintain continual inspection readiness(mock inspections readiness rooms storyboards interview prep evidence lists).
Coordinate and client/internal QA auditsendtoend: planning conduct documentation and closure.
Define and run the PV compliance dashboard: RFT (RightFirstTime) ICSR timeliness deviation & CAPA cycletimes EC pass rate training compliance SOP adherence audit finding aging.
Lead trend analysisand risk reviews; drive preventative improvements (process simplification job aids automation opportunities).
Serve as the single point of contactfor PV QA/Compliance topics for the project collaborating with Delivery Lead workflow Managers and client.
Provide concise datadriven updatesto client and internal leadership; ensure transparent risk logsand mitigation plans.
.
Skills & Knowledge:
- Handson CAPA author and critical thinkerwho proactively prevents recurrence through robust rootcause analysis (RCA)and effectiveness checks while partnering with delivery leads QA medical safety and client stakeholders.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies
Affiliated Companies: PharmaLex India Private Limited
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.
The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Manager
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company ...
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Responsibilities:
Triage deviations/quality events; perform causeandeffectanalysis(e.g. 5 Whys Fishbone) identify true root cause(s) and draft clear testable CAPAswith owners due dates measurable outcomes and effectivenesscheck (EC) plans.
Author and review CAPAsto a publishable standard (concise problem statement containment corrective preventive verification/validation residual risk).
Steward CAPA lifecycle: tracking timely closure EC results trend recurrence and lessons learned.
Own the PV Quality Management System (QMS)controls for the project ensuring alignment to ICH EU GVP FDA MHRA and client procedures.
Design and facilitate CAPA & Compliance forumsfor OPE and delivery teams (short learning bursts case studies error prevention What good CAPA looks like).
Maintain continual inspection readiness(mock inspections readiness rooms storyboards interview prep evidence lists).
Coordinate and client/internal QA auditsendtoend: planning conduct documentation and closure.
Define and run the PV compliance dashboard: RFT (RightFirstTime) ICSR timeliness deviation & CAPA cycletimes EC pass rate training compliance SOP adherence audit finding aging.
Lead trend analysisand risk reviews; drive preventative improvements (process simplification job aids automation opportunities).
Serve as the single point of contactfor PV QA/Compliance topics for the project collaborating with Delivery Lead workflow Managers and client.
Provide concise datadriven updatesto client and internal leadership; ensure transparent risk logsand mitigation plans.
.
Skills & Knowledge:
- Handson CAPA author and critical thinkerwho proactively prevents recurrence through robust rootcause analysis (RCA)and effectiveness checks while partnering with delivery leads QA medical safety and client stakeholders.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies
Affiliated Companies: PharmaLex India Private Limited
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.
The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Manager
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