Senior Specialist - Quality Audits

Date: 3 Jan 2025

Location: SE

Company: AdvanzPharma

Job Title: Senior Quality Auditor Location: Sweden or Ireland MUST HAVE STERILE EXPIERENCE About ADVANZ PHARMA ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMAs product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. What Youll Do:

• Mentoring of team members
• Lifecycle Management of Advanz Pharmas 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 Advanz Pharmas 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 SOPs / 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

Why ADVANZ PHARMA? The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing the specialty and hospital medicines they depend on. As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, youll be empowered to own your work, explore new possibilities and make things happen. But theres more to you - and us - than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles - we have an active ADVANZ PHARMA Womens Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. To join us on our exciting journey, Apply now! *

• Please include a CV and Cover letter.