Role DescriptionYou will be leading a team of (Senior) Quality Assurance Officers on execution of quality assurance activities and you will be the main link between the team and the QA Director You also will be responsible for planning and execution of daily quality assurance while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.
ResponsibilitiesSuggest process improvements and actively follow up improvement programs. Monitor compliance with all applicable GMP and safety standards in the area of quality assurance. Support the Qualified Person in his role, including audits and quality training. Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents. Suggest training activities. Involved in planning activities in cooperation with the Manager QA / Director Quality Provide guidance to (senior) QA Officers. Plan and execute quality assurance activities (document management, batch record and label issuance, batch record review, equipment and supplier qualifications) including documentation. Prepare data for trending (QRB, Annual Product Review) and support and attend internal and external audits.
Requirements- Minimum Bachelor degree in Science or similar qualification (Cosmetic, Food or Pharma) . - Good knowledge of continuous improvement - Excellent relationship manager, influencer and communicator. - Experience in project management and technical writing. - Profound knowledge of Microsoft Office Programs and SAP
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.