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!
Job Details Responsibilities:
Triage deviations/quality events; perform cause‑and‑effect analysis (e.g., 5 Whys, Fishbone), identify true root cause(s), and draft clear, testable CAPAs with owners, due dates, measurable outcomes, and effectiveness‑check (EC) plans.
Author and review CAPAs to 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 forums for 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 audits end‑to‑end: planning, conduct, documentation, and closure.
Define and run the PV compliance dashboard: RFT (Right‑First‑Time), ICSR timeliness, deviation & CAPA cycle‑times, EC pass rate, training compliance, SOP adherence, audit finding aging.
Lead trend analysis and risk reviews; drive preventative improvements (process simplification, job aids, automation opportunities).
Serve as the single point of contact for PV QA/Compliance topics for the project —collaborating with Delivery Lead, workflow Managers and client.
Provide concise, data‑driven updates to client and internal leadership; ensure transparent risk logs and mitigation plans.
.
Skills & Knowledge:
- Hands‑on CAPA author and critical thinker who proactively prevents recurrence through robust root‑cause analysis (RCA) and effectiveness checks, while partnering with delivery leads, QA, medical safety, and client stakeholders.
What Cencora offersBenefit 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 CompaniesAffiliated Companies: PharmaLex India Private Limited
Equal Employment OpportunityCencora 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 company’s 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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
