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A new possibilty as Senior Quality Auditor at a pharmaceutical company in Region Öresund!
Location: Sweden, Skåne
Must have Sterile Experience
What You’ll Do
• Mentoring of team members
• Lifecycle Management of Company’s approved vendors/suppliers in accordance with the appropriate industry regulations and guidelines
• The role requires cross-functional/departmental interactions working closely with Supply Chain, Regulatory, and Quality colleagues to ensure qualification activities are aligned to business requirements
• This role will require national and international travel
• Deputise for Senior Quality Manager – Supplier Assurance as required
• Establish KPIs and evaluate and report associated metrics
• Monitor a risk-based audit programme for vendors/suppliers used in Comany’s products (excluding Pharmacovigilance suppliers/partners)
• Perform a risk analysis-based outcome on Quality audit and liaise with QPs and management on future actions.
• Ensure audits are carried out such that assurance is provided for all vendors/suppliers in accordance with current EU GMP, EU GDP or equivalent, and the relevant marketing authorisation (MA)
• Monitor and maintain CAPAs (both internally and with external suppliers)
• Responsible for maintaining vendor validity in the SAP ERP system
• Evaluate and interpret global regulations for audits
• Create, revise and review documentation related to QA audit checklist, questionnaire etc., and other system SOP’s / guidance documents as required by the management
• Other activities as may be required at the discretion of the Senior Quality Manager – Supplier Assurance
About You
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.
For this role, you will also have the following:
Qualifications
• Graduate in Chemistry, Pharmacy or Microbiology or equivalent
• General Auditing Qualification
• External Lead Auditing Qualification
Experience & Competences
• Minimum 5 years’ experience of working in a similar role within a pharmaceutical company
• Familiarity with the directives and guidelines for Medical devices
• Able to travel within globally
• Capable of working to deadlines & remain calm under pressure
• Proven ability to organize and prioritize multiple tasks
• Ability to work on own initiative & juggle priorities
• Ability to make decisions based on risk
• Ability to work effectively as part of a team
Knowledge & Skills
• Excellent communication skills, both oral and written, to include senior management in third party suppliers
• Well organised with logical & methodical approach to work
• Sound problem solving skills
• Good organisation & time management skills
• Proven auditing skills
Personal Qualities
• Excellent interpersonal, communication and organizational skills
• Helpful and flexible with strong team spirit
• Attention to detail and focus on Quality.
• Problem solving and solutions orientated, demonstrate flexibility and adaptive to change
• Strives consistently to overachieve with high standards
• Approaches work with a sense of urgency, Ability to work under pressure and to tight deadlines.
• Analytical mind-set, with good problem-solving skills
Contact me for more information about the company and a discussion regarding the role!