QA Expert - ReleaseApply Now Email Me Job ID SR0032463 Date posted 01/31/2019 Location:Neuchâtel, Switzerland
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality Assurance (QA) Expert - Release 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, focusing on the latter process.
The QA Expert is the QA representative for both routine GMP activities and Takeda projects.
She/He 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, mainly to present the processes and procedures related to the product release process.
QA Expert shall promote and be involved in Continuous Improvement.
Essential duties and responsibilities
- Participate to the Quality daily activities related to the batch record review and product release, mainly related to aspectic processes.
- Be an expert of the release process and handling of item codes for bulk drug substance anf final container products.
- 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 Takeda employees. Takeda expects all employees to embody the following:
- Be Positive
- Be Accountable
- 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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.