Quality Manager - Audits

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Quality Manager - Audits

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ADVANZ PHARMAJoin to apply for the

Quality Manager - Audits

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Manager – Quality AuditsLocation: LondonAbout ADVANZ PHARMAADVANZ 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 PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics and 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.Main purpose of role:Leadership, management and mentoring of direct reportsLifecycle Management of Advanz Pharma’s approved vendors/suppliers in accordance with the appropriate industry regulations and guidelinesThe role requires cross-functional/departmental interactions working closely with Supply Chain, Regulatory, and Quality colleagues to ensure qualification activities are aligned to business requirementsThis role will require national and international travelDeputise for Senior Quality Manager – Supplier Assurance as requiredKey responsibilities:Establish objectives, KPIs and evaluate and report associated metricsEstablish, maintain and monitor a risk-based audit programme for vendors/suppliers used in Advanz Pharma’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 systemEvaluate and interpret global regulations for auditsCreate, revise and review documentation related to QA audit checklist, questionnaire etc., and other system SOP’s / guidance documents as required by the managementOther activities as may be required at the discretion of the Senior Quality Manager – Supplier Assurance as requiredAbout YouWe 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:Knowledge, Skills and Experience:Graduate in Chemistry, Pharmacy or Microbiology or equivalentGeneral Auditing QualificationExternal Lead Auditing QualificationMinimum 5 years’ experience of working in a similar role within a pharmaceutical companyExperience and auditing against with the directives and guidelines for medical devicesExperience and auditing sterile manufacturing facilitiesExperience and auditing against with the directives and guidelines for biosimilarsAble to travel globallyCapable of working to deadlines and remain calm under pressureProven ability to organize and prioritize multiple tasksAbility to work on own initiative and juggle prioritiesAbility to make decisions based on riskAbility to work effectively as part of a teamExcellent communication skills, both oral and written, to include senior management in third party suppliersWell organised with logical and methodical approach to workSound problem solving skillsGood organisation and time management skillsExcellent interpersonal, communication and organizational skillsHelpful and flexible with strong team spiritWhy 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, you’ll be empowered to own your work, explore new possibilities and make things happen.But there’s 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 Women’s 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.ADVANZ PHARMA''s Commitment to Equal Employment Opportunities: Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated. ADVANZ PHARMA is committed to providing equal employment opportunities for all employees and prospective employees without regard to race, color, religion, sex, age, national origin, ancestry, sexual orientation, marital status, disability, or other protected classifications to the extent required by applicable laws. In all instances, the company will continue to comply with all local laws governing employment practices. In addition, the company will make reasonable accommodation for any applicant or employee with a disability, both during the application process and on the job, whenever possible.Seniority level

Seniority level Mid-Senior levelEmployment type

Employment type Full-timeJob function

Job function Quality AssuranceIndustries Pharmaceutical ManufacturingReferrals increase your chances of interviewing at ADVANZ PHARMA by 2xGet notified about new Quality Assurance Manager jobs in

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