Compliance Auditing, documentation
vor 1 Tag
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 activitiesKey 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, Results and Customer oriented Previous people management experience (either direct or indirect) Fluency in French and English Excellent knowledge of GMP and regulatory expectations Excellent communication skills Ability to influence people Role model in GxP, HSE and Haleon values expectationPlease save a copy of the job description, as this may be helpful to refer to once the advert closes.
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.
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.
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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