Temporary Quality Assurance Specialist

Randstad Türkiye

We are looking for a  "Temporary Quality Assurance Specialist" to our global company in biopharmaceutical sector.

Qualifications

• 5 years+ of hands-on Quality Assurance experience in pharmaceutical/ biotech industry.
• 2 years+ of hands-on experience in the production, quality assurance and quality control activities in one or multiple manufacturing sites
•  Experience in product release and cold-chain distribution activities
•  Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
•  Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GxP and Pharmacovigilance required
•  Ability to work globally in a matrix environment
•  Ability to influence - management, peers and other colleagues without direct reporting lines
•  Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
•  Experience in using SAP system.
•  Experience in using computerized systems for Change Control, Deviation and CAPA management
•  Advanced English level (both written and spoken)
•  Leadership ability
•  Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
•  Good communication and interpersonal skills
•  Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
•  Ability to freely travel up to 30% (domestic and international)

Responsibilities:

• Partner and collaborate with leads and colleagues to ensure the roll out and on-going compliance to global quality and compliance systems, and associated procedures and standards.
• Ensure the Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GDP, GxP and PV guidelines.
• Provide internal auditing resource to assess compliance on a regular basis.
• Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GDP/GxP/PV audits.
• Provide Quality competence to the designated Affiliate and lead local/regional Quality activities
• Quality Systems support contact within specific designated country
• Could act as SME/Super user for key systems as part of the QMS
• Create/revise procedural documentation
• In collaboration with the Sr, Manager Country Quality, weigh and communicate quality and compliance risks as appropriate
• Could act as Quality liaison between the local operational groups and Corporate Quality for GDP/GxP/PV functions and activities.
• Together with Sr, Manager Country Quality, partner with local, regional and global operational groups to foster a proactive approach to compliance.
• Interactions with regulatory health authorities, in alignment with Sr. Manager Country Quality, in case of potential falsification, diversion, counterfeit, theft, etc when needed.
• Approve and maintain quality agreements with vendors relating to distribution and/or transportation of medicinal products.
• Ensuring that a quality management system is implemented and maintained;
• Focusing on the management of authorised activities and the accuracy and quality of records;
• Ensuring that relevant customer complaints are dealt with effectively;
• Ensuring that suppliers and customers are approved;
• Ensuring that self-inspections are performed at appropriate regular intervals following a
• prearranged programme and necessary corrective measures are put in place;
• Keeping appropriate records of any delegated duties;

Randstad is an authorized agency of İskur with the licence date number : 17.10.2006 - 191