Quality Assurance Specialist

 Jobomas DE
 Deutschland, Frankfurt, Hessen
 vor 1 Tag, 20 Stunden
Quality Assurance Systems Lead Do you have previous experience in Quality Assurance systems in the pharmaceutical industry? Are you looking for an opportunity to set up and be at the forefront of a brand new digitalised Quality system? Are you located in Frankfurt, Germany, or are you willing to relocate? Fraser Dove International is working exclusively with an established Global Pharmaceutical organisation. Our client is seeking a leader to provide strategic direction to our client’s QMS and implement change management. Discover more about our Quality Assurance Systems Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed. Your objectives: As the Quality Assurance Systems Manager, you will be measured against the following objectives: Providing process support during clinical development and or commercial activities Including process validation as needed. Leading overall change management, implementation, and compliance with QMS policies. Responsible for providing Quality leadership on new technology, new opportunities and large projects and technology transfers. What you will do: As the Quality Assurance Systems Manager, your duties and responsibilities will include: Acting as the first point of contact for QA related projects and ensuring empowerment to QA teams. Provides process support during clinical development and or commercial activities Including process validation as needed. Responsible for providing Quality leadership on new technology, new opportunities and large projects and technology transfers. Coordinating and synthesising the regional needs in QMS over the region. Collaborate, review, and approve all product related change controls, Master Batch records, and cleaning documents. Liaison between QA and other departments for Review and Approval of all required change controls for products they are representing. Facilitates review and approval of documents with other QA specialists if needed. Assures that manufacturing processes, packaging and testing comply with all regulatory filings and SOPs to ensure favourable quality inspections and customer satisfaction. Serves as Q liaison to the technical department and on product/project implementation teams. Supports the Implementation of new processes and new business opportunities proposed for implementation into development and/or manufacturing. What you will bring: These are the skills and experience you will need to succeed as the Quality Assurance Systems Manager: · Ability to solve problems and to escalate in a concise way. · Strong knowledge of QMS applied to manufacturing and distribution, as well as medicinal regulation. Project management experience although not required is beneficial to this position. Excellent customer service skills. Knowledge of cGMP, cGLP and FDA regulations, as well as internal quality related procedures. Practical and theoretical knowledge of the basic principle of validation and their applications. Analytical ability and ability to influence. Excellent verbal, presentation, and written communication skills. Ability to provide leadership in all aspects of QA/development processes. Analytical skills with the ability to function in an interactive interdisciplinary team environment. Proactive approach to problem solving and resolution. Ability to read, analyze, and interpret common scientific and analytical journals. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to communicate information to customers and senior management. Ability to effectively present information to top management, public groups. What you will get: These are the perks and benefits that will complement your generous base salary: · Bonus Got what it takes? To apply for the Quality Assurance Systems Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – on +44 (0)203 355 7050. Please Note: · This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments. · If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion. · We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: https://www.fraserdove.com/privacy-policy/ ****** Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patients lives

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