Website Asset Recruitment
Asset Recruitment
ref 01106
QA Specialist
Responsibilities:
• Focused on improvement of quality-related issues to ensure excellent quality of released products and processes.
• Responsible for releasing incoming goods, products whose production or packaging is outsourced and processes and products in full compliance with quality procedures and guidelines, legal guidelines and market authorization.
• Ability to communicate quality requirements for introducing materials on site to suppliers.
• Use of good documentation practices and capable to implement them at the local level.
Role:
• The successful candidate will work across the self-directed work team/hub at the site to identifying and troubleshooting issues to enable the site to deliver on our culture, which supports Quality, EHS, Learning and Continuous Improvement. This role will provide Quality Assurance (QA) oversight for technical transfers, qualification/validation, regulatory approvals and commercial operations.
• Responsible for oversight of Quality Systems across the site including supporting the Engineering, Operations, MS&T, QC teams and Plan and Procure teams, assuring compliance with corporate and cGMP regulations.
• Supports the Operations, Engineering, MS&T, QC and Plan and Procure teams, ensuring compliance with cGMP and corporate regulations.
• Work aligned with internal partners (e.g. Manufacturing Operations, MS&T, Engineering functions etc) in support of daily operations.
• Supports the coaching and development of key members of the QA Operations and Quality Systems teams to achieve a high performance organizational culture that enable rapid growth and highly dynamic expectations.
Requirements:
• Degree or post-graduate qualification in Pharmacy, Science or similar.
• 9 y+ experience in the Biotechnology and/or Pharmaceutical industry desirable.
• Expertise to effectively communicate within all levels of the organization around concepts of design verification, design controls and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Proven record of accomplishments in a Regulated Industry.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
• Exceptional analytical, problem solving & root-cause analysis skills.