Requires a minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation preferred* Excellent troubleshooting skills; able to identify root cause of problem required* Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing QC, IT & process utilities preferred* Excellent written & verbal communication skills required* Auditing experience with certification preferred (internal/external) required* Experience with LEAN, Six Sigma & other continuous improvement methodologies required* Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation) preferred* Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required* Expert in utilizing appropriate root-cause analysis tools & techniques preferred* Experience with Risk Assessment & Risk Management required* Demonstrated excellence with time management, organizational & project management skills requiredWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants. *If hired as a AQP, Bachelor's degree in Life Sciences or a relevant field of study from an accredited university required* Minimum of seven (7) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field required* Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred* Quality Risk Management experience required* Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity required* Experience in use of Risk Assessment & Vendor Assessments during evaluation of change controls, deviation and validation activities required* Expert in cGMP documentation practices.