Role DescriptionMaintain a team that has the technical expertise, personal skills and interpersonal skills needed to perform their duties in line with Site expectations. Instruct employees and delegate duties as well as powers, in consultation with the persons involved Ensure an effective internal communications structure with relevant departments Supervise the performance of the work (both in terms of volume and quality) as well as the lead time Measure and Monitor Execution: Consistently measure and monitor site quality key performance indicators. Manage Department Processes: Including and not limited to timely management of investigations, CAPAs, coordination of Regulatory commitment, GRAs, Audits, standard implementation to ensure sustainable compliance. Manage team through talent identification, active performance management, succession planning, employee development, mentoring and modeling behavior according to values. Maintain a team that understands and maintains the rigorous standards required while retaining the flexibility to adapt to continuous evolution and change.
ResponsibilitiesEnsure robust quality systems that include monitoring and control of the manufacturing process and facilities This includes the quality systems, manufacturing, packaging, testing, facilities and warehousing methodologies and technologies related to Teva Operations including GXP IT systems.
Change Control Ensure that proposed changes to suppliers, processes, equipment, systems, procedures, and basic documents are assessed according to current CGXP guidelines en Global requirements.
Validation Ensure that validation protocols are developed according to cGXP standard , processes, equipment, systems, procedures, and basic documents are assessed according to current CGXP guidelines en Global requirements. Manage validation status of Site’s utilities, equipment and processes Ensure that validation of systems, equipment and processes are timely performed and reported, inform management of any discrepancy. Assure that validation of systems, equipment and processes are in accordance with current USP / Ph. Eur / JP and registration files
Documentation Ensure that SOP´s are developed according cGXP guidelines and Global requirements. Manage the documents in a robust EDMS and ensure proper archiving for non EDMS documents. Assure that analysis methods are in accordance with USP / Ph. Eur / JP and files.
Transfers Ensure product transfers across sites also include the transfer of quality information (knowledge, documentation, processes, etc.). Coordinate requested and available capacity; deciding on outsourcing Support transfer of analytical methods to other sites as part of the Transfer TeamSupport the receiving and implementation of methods for new products from other sites as part of the Transfer Team
cGXP Prepare and implement department policies and objectives in line with Site policies Ensure the implementation of and compliance with national and international quality standards (cGXP) as well as Teva Global standards Execute the review and implementation of standards and procedures at the department. Maintain adherence to corporate policies and appropriate regulations through actions and decisions. Ensure that all current standard operating procedures are accurate, current with regulatory guidance and aligned with cGXPs Assure internal as well as external complaints are investigated on behalf of the Quality Assurance department or other departments
Requirements- Experienced QMS Head / Director / Consultant - Experience with the tasks described above
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Amber Moet.