Compliance Auditing, Documentation

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
- Inspection Readiness process: 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 KPls, 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 KPls, 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 KPls, trends findings and escalate any significant gaps.

4. GSK AUDIT / HA INSPECTION CUSTOMERS AUDIT

Support the QA Release, Compliance and Auditing Senior Manager for audit/inspection organization. Review and approve, in collaboration with QA Release, Compliance and Auditing Senior

Manager proposed corrective/preventive action plans.

Manage CAPA follow up in accordance with Global CH guidance and local SOP

Verify implementation and effectiveness of agreed corrective/preventive actions (Suitability of provided evidence and attachment in GXP audit system)

Issue monthly report for KPls

Report and trend audit observations.

5. 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.

6. DOCUMENTATION

Oversee the design, delivery, development and renewal of the site’s documentation program, including both hard copy and electronic documentation and ensure that associated documentation ‘SOPs, Forms, protocols, reports, etc) are governed by a clear, simple and appropriate process.

7. TRAINING

Design, deliver, implement, and maintain a comprehensive training program for the Nyon manufacturing plant for compliance based and priority training initiatives to include GMP, EHS, technical production skills, regulatory compliance and new employee on-boarding. Partner with SOP owners, Permanent Inspection Readiness SME to determine training applicability for new or revised SOPs as appropriate and annual training updates. Oversee the design, delivery and continuous improvement of site-based qualification processes.

8. PEOPLE MANAGEMENT

People management of direct reports which are both independent contributors as well as managers of other associates (e.g. SME of PIR)

9. GMP and HSE

Respect all GxP standards and HSE requirements at Nyon plant. Ensure associates respect local GxP and HSE requirements and escalate any significant issue observed.

Qualifications and skills

Essential
- 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, R