Quality Audits & Inspections Auditor EMEA (m/f/d)

Location
Berkshire, United Kingdom
Salary
Competitive
Posted
16 Oct 2020
Closes
14 Nov 2020
Ref
46560
Job role
Accountant
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

YOUR TASKS AND RESPONSIBILITIES

This QAI Auditor (m/f/d) position belongs to the regional Audit Program Management EMEA managing operational GMP/GDP audit tasks for the regionEMEA. It is part of the audit management set-up of Corporate Quality - Quality Audits & Inspections. In detail you:

  • Prepare, perform and effectively manage quality audits according to the respective audit program at Bayer manufacturing sites, affiliates, external contract manufacturer as well as suppliers and service providers of the divisions PH, CH and AH
  • Systematically assess the established quality systems and processes and determine the compliance status in relation to internal and external regulations and Bayer requirements
  • Provide independent risk-based and objective compliance assessments and drive risk mitigation as the basis for corresponding follow up decisions
  • Identify and escalate any potential or confirmed critical deficiencies detected during audits in a timely manner
  • Collect, analyze and summarize objective evidence and information as basis for the audit report
  • Develop solutions/recommendations for suitable measures in collaboration with the auditee to ensure GMP compliance and supply chain continuity for products
  • Identify opportunities for continuous improvements with regard to GMP/GDP requirements
  • Review and approve corrective and preventive action plans (CAPA plans)
  • Verify CAPA implementation and effectiveness during audits


WHO YOU ARE

  • University degree in pharmacy, engineering, biology/chemistry, IT or related science with extensive experience in auditing
  • Several years of GMP experience in pharmaceutical, biotechnological or medical devices industry or related
  • Ability to analyze and judge on complex data in areas specific to job function at advanced level
  • Strong technical writing skills
  • Good understanding of technical and scientific topics
  • Effective planning and organizational skills and attention to detail
  • Strong communication skills with the ability to communicate at all levels within the organization
  • Distinct intercultural competence and willingness to travel
  • Fluent English in written and verbal communication, second language is preferred


YOUR APPLICATION Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people's lives? Then send us your online application including cover letter, CV and references.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location: LeverkusenDivision: Reference Code:

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