Compliance Auditing, documentation

vor 7 Stunden

Nyon, Schweiz TN Switzerland Vollzeit

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Client:

Haleon

Location:Job Category:

Other

Job Reference:

3343d765d223

Job Views:

9

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

About the role

  • Lead internal audits of GSK Nyon plant departments for the purpose to identify any non-compliance to the GSK QMS, National / International GxP requirements, and Local Standard Operating Procedures.
  • Local process owner for self-inspection, internal and external audits.
  • Support Inspection/Audit of Nyon plant by Health Authorities, GSK group (CAG, A&A), Customers and Notified Body (SQS), prepare audit and Inspection answers, follow action plan and document action closure.
  • Manage Documentation and training activities.

Key Responsibilities

  1. SELF INSPECTION: Local process owner of the Self-Inspection process: define SOP and template according to Global CH guidance, define training program and train designee associate, review and approve audit universe, define and report KPIs, trends findings and escalate any significant gaps.
  2. INTERNAL AUDIT: Local process owner of the Internal Audit process: define SOP and template according to Global CH guidance, define training program and train designee associate, define internal audit universe and internal audit program in collaboration with the QA Release, Compliance and Auditing Senior Manager, conduct internal audit and issue report, approve proposed CAPA, follow CAPA closure on time, define and report KPIs, trends findings and escalate any significant gaps.
  3. EXTERNAL AUDIT: Local process owner of the External Audit process for Nyon site services providers not integrated in the SQA&C program. Define SOP and template according to Global CH guidance, define training program and train designee associate, define audit universe and external audit program with the QA Release, Compliance and Auditing Senior Manager, conduct external audit and issue report, approve proposed CAPA, follow CAPA closure on time, define and report KPIs, trends findings and escalate any significant gaps.
  4. Support the QA Release, Compliance and Auditing Senior Manager for audit/inspection organization. Review and approve proposed corrective/preventive action plans.
  5. Manage CAPA follow up in accordance with Global CH guidance and local SOP.
  6. Verify implementation and effectiveness of agreed corrective/preventive actions.
  7. Issue monthly report for KPIs.
  8. Report and trend audit observations.
  9. CONTINUOUS IMPROVEMENT: SME for Auditing process. Author and review Standard Operating Procedures, as needed. Complete Lessons Learned and share Best Practices resulting from audits/inspections in Nyon plant.
  10. DOCUMENTATION: Oversee the design, delivery, development and renewal of the site’s documentation program, including both hard copy and electronic documentation.
  11. TRAINING: Design, deliver, implement, and maintain a comprehensive training program for the Nyon manufacturing plant.
  12. PEOPLE MANAGEMENT: People management of direct reports including independent contributors and managers.
  13. GMP and HSE: Respect all GxP standards and HSE requirements at Nyon plant.

Qualifications and skills

  • University degree in Quality Assurance, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
  • Pharmaceutical industry specialization.
  • Minimum 5 years of experience in the pharmaceutical industry within the quality assurance function.
  • Experience in auditing activities.
  • Haleon/GSK certified auditor.
  • Good interpersonal and leadership skills.
  • Safety, Quality, Results and Customer oriented.
  • Previous people management experience.
  • Fluency in French and English.
  • Excellent knowledge of GMP and regulatory expectations.
  • Ability to influence people.
  • Role model in GxP, HSE and Haleon values expectation.

Diversity, Equity and Inclusion

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.

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