Shire QA Expert - Release in Neuchatel, Switzerland
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. In 2016, Shire grew its organization to approximately 24,000 employees+ globally, following integrations of Dyax and Baxalta.
An exciting and challenging opportunity has become available at Shire Neuchâtel Plant (approx. 650 employees) for a Quality Assurance (QA) Expert position.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Assurance teams within a world-class Biotech manufacturing environment.
Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release processes.
The QA Expert is the QA representative for both routine GMP activities and Shire projects. He/She has to ensure quality of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.
Participation in GMP audits will be part of activities.
QA Expert shall promote and be involved in Continuous Improvement.
Essential duties and responsabilities
Participate to the Quality daily activities related to the batch record review and release.
Participate to the Quality daily activities related to raw materials (release, specification implementation, etc...)
Provide quality oversight in term of solving problems/root cause for deviations and CAPA.
For change control, review and evaluate change requests according to processes, methods, quality systems and applicable regulatory files to meet Corporate, Divisional and Regulatory requirements.
Be a leader in the implementation of facility projects in conformance with regulatory requirements.
Education & Experience
University degree in Engineering, Biotechnology, Pharmacy, or Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies.
Knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards.
Knowledgeable in auditing and inspection against regulatory / Quality standards.
Solution oriented and ability to simplify the complex.
Good listener, team oriented and good communication skills
Good organizational skills and continuous improvement mindset
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.