Corporate Quality Auditor GMP (project mode) M/F
- Recruiter
- Sanofi Global (French)
- Location
- Antony, France
- Salary
- Competitive salary
- Posted
- 09 Jun 2021
- Closes
- 17 Jun 2021
- Ref
- R2586335
- Job role
- Audit
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.
PURPOSE OF THE POSITION
Mains:
Specifics : Knowledge / experience / expertise in the field of:
MAINS RESPONSABILITIES
Dimension (ex. : Budget, number of headcount to manage) :
REQUIS
Diploma Level / Experience :
Technical skills &Specifics Knowledges / Language:
Expertise in :
Behavioral skills (LEAD and others):
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.
PURPOSE OF THE POSITION
Mains:
- Provides an accurate, independent GMP/GDP/CS assessment of sites and third parties, for GMP/ICH compliance with applicable regulations and Corporate Quality Policy / requirements through audit, and support activities
- Contributes to CS/ITS quality audits and System Validation related documentation
- Makes sure through audits that operational units are compliant with Regulatory and Company requirements and that suppliers are aligned with GMP / ICH expectations and with approved Quality Agreements
- Contributes to define the Quality Audit methodology and related quality documentation of EuroAPI
- Ensures the implementation of quality documentation across the group through sites audit, networking and trainings
- Accountable for mentoring sites, colleagues and new auditors under qualification regarding GMP/GDP/CS requirements
Specifics : Knowledge / experience / expertise in the field of:
- Manufacturing and development in Chemistry, Biochemistry, Biotechnology APIs and in Drug Products
- Quality Management System/ Quality Assurance / Quality Control /Quality Risk Management/ Regulatory Affairs related processes and GxP applicable regulations
- Computerized systems
- Distribution and transportation
MAINS RESPONSABILITIES
- Provides an accurate, independent GMP/GDP/CS assessment of sites and third parties for compliance with Corporate Quality Policy / requirements and applicable regulations through audit and inspection support activities
- Contributes to CS/ITS quality audits and System Validation related documentation
- Acts as a lead auditor or co-lead auditor for EuroAPI sites audit
- Acts as lead auditor for supplier audits
- Participates actively on the defined auditing program for GMP/GDP/CS perimeter and ensures that auditing activities are effectively carried out according to the audit strategy
- Defines his/her annual audit program and manage reporting of audit activities and audit outcomes in timely manner
- Conducts GMP/GDP/CS audits worldwide (Significant part of the time dedicated to international travel)
- Prepares, issues, reviews, and approves audit reports in a timely manner
- Approves/manages audit CAPAs to agreed timelines
- Performs due diligence activities when requested
- Contributes to define the GMP/GDP/CS Quality Audit policy and related quality documentation
- Ensures the implementation of documentation across the group through sites audit, regular networking and trainings
- Manages audit activities subcontracted to external audit partners when required
- Assists with the integration of newly acquired entities, including through the performance of baseline audits
- Interacts in the audit network and directly with Quality Management at Operational Quality Units to ensure good governance of the auditing activities, audit findings and related CAPA
- Contributes to promote and participate on a Quality Assurance Supplier Network to assist in sharing of audit activities, information, identification of best practices and actions on continuous improvement related to audits activities
- Contributes to support Regulatory Inspections for GMP/GDP/CS activities with sites
- Keeps up to date with current and forthcoming GMP/GDP/CS regulatory authority requirements, and relevant Corporate Quality Documents
- Trains colleagues and sites, ensuring knowledge in regulation's changes regarding Digital and Computerized System Compliance as well as GMPs
- Assists in fulfilling responsibilities of other auditors of the team, particularly during periods of his or her absence (e.g. while on vacation)
- Navigates comfortably in all team's missions and commitments, accountable as team members back-up as required
- Contributes on the documentation sharing through erooms and sharepoints
Dimension (ex. : Budget, number of headcount to manage) :
- The role is key to ensuring that the company has a robust and effective quality audit system covering all its business activities
- The role holder works directly with all Operational Quality teams (Operation Quality Units, Quality System, Regulatory), other internal functions (ITS, operations, ...), external third-party vendors, business partners, and country specific Regulatory Authorities during Inspections, etc., as required
- The role holder is required to work autonomously and to take decisions in line with Regulatory requirements and Corporate Policy, Standards and Processes
- The role ensures transversal interactions with the different entities of the group (Quality functions, Operations, procurement, IT, ...)
- The role holder reports to Corporate Quality Audit Head and interacts actively with his/her colleagues, as back-up one to each other's
- If applicable, the role holder oversees supervising external subcontractors which would perform audits on behalf of the company
REQUIS
Diploma Level / Experience :
- Minimum Bachelor's Degree in Science, Science Graduate or equivalent
- +10 years in Pharma/API industry or a major Regulatory Authority
Technical skills &Specifics Knowledges / Language:
Expertise in :
- Auditing
- Manufacturing and Quality Control
- Continuous improvement management
- Quality risk analysis and Quality risk management
- Quality systems
- Advanced Knowledge in GxP and health-related regulations and company requirements, specifically pharmaceutical drug/API Regulations, e.g. FDA/EMA, GxP, ICH
- Advanced Knowledge of CS validation and quality requirements
- GxP expertise+
- Knowledge of IT tools
- Foreign language (English) is a Must
Behavioral skills (LEAD and others):
- Highly independent and compliance mindset
- Ability to adapt in different cultural situations
- Easy communication and soft power
- Strive for results
- Decisions Making
- Take actions autonomously
- Be accountable of his/her decisions
- Put interests of the organization ahead of his/her own
- Drive a culture of continuous improvement to improve processes and organization effectiveness
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.