Periodic Product Review and Complaints Coordinator (6 months secondment)

☞ Haleon

Aussicht: 76

Update Tag: 25-03-2024

Ort: Nyon Vaud VD

Kategorie: Pharma / Chemie / Biotechnologie Beratung / Kundenservice Recht / Verträge

Industrie:

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Jobinhalt

Write Periodic Product Review (PPR), develop and implement associated CAPA plans in compliance with GMP requirements and internal Haleon guidelines and timelines.
  • Handling customer complaints of product manufactured at Nyon plant with respect of GMP requirements and internal Haleon guidelines. Take in charge the end to end process of customer complaints management system: technical investigation with department involved, complaint investigation report writing, CAPAs implementation, and follow-up until complaint record is closed.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Regulatory / GMP Compliance: PPR Activity
  • Extract records of our systems and perform the statistical trend analysis
  • Write PPR and assessed data for all sections of the PPR document
  • Contribute to and implement associated CAPA plans in compliance with Regulatory/GMP requirements and Haleon guidelines.
  • Escalate immediately any quality issue or non-compliance issue
Regulatory / GMP Compliance: Customer complaints Activity
  • Technical investigation of customer complaints received for products manufactured at Nyon plant and participation on problem solving related to complaints investigation process
  • Follow-up that all related records (CRMS, Deviations, CAPAs, …) are completed correctly and on time
  • Escalate critical complaints according to local SOP requirements
Continuous improvement:
  • Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work
  • Drive and improve KPIs related to PPR and Customer complaints activity according to the timelines defined
Customer orientation/services:
  • Establish and actively maintain “Customer Service” relations in accordance with Haleon values with internal site customers and external customers (Health Authorities, Local QA and QP)
  • Answer questions raised by local QA/QP regarding PPRs or Customer complaints
GMP:
  • Respect all GMP standards. GMP knowledge and experience to support the requirements expected by Swissmedic, European Union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system. Update SOPs and others GMP documents related to complaints and PPR management system.
  • Support inspections and audits
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
  • University degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
  • Minimum of 3 years’ experience in the pharmaceutical industry within a quality assurance function or equivalent
  • Driven for accurate and detailed results, while exercising good judgement
  • French : fluent (oral and written)
  • English : fluent (oral and written)
  • Good level of coordination and communication
  • Customer oriented
  • Good level for IT system use (Veeva, SAP, EDMS, …)
  • MS Office : good command
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.
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Frist: 09-05-2024

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