Quality Assurance Specialist - Turkey-MEA
About Astellas
At Astellas, experience is coupled / energised with a relentless challenger spirit.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutions and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
About This Job
As Quality Assurance Turkey-MEA (T-MEA), you will support the implementation and administration of a comprehensive Pharmaceutical Quality System for the T-MEA area.
In this position, you will report into the Lead, Quality Assurance T-MEA and be involved in providing
oversight for Quality activities at T-MEA Third Party Logistic providers (3PLs)
Hybrid working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Key Activities:
- Support the establishment, implementation, and maintenance of the Quality Management systems for deviation management, complaint handling, change control, supplier management, annual product review and quality agreements for T-MEA.
- Act as the back-up to the QA Lead for T-MEA as well as the Deputy Responsible Manager in Turkey.
- Provides SOP training for 3PLs and TMEA personnel
- Supports product release process.
- Provide support for T-MEA Inspection Readiness activities.
- Generating Quality metrics for Quality management.
- Process deviations: transportation deviations, damage reports, product returns, and stock discrepancies, review, documentation, and follow-up.
- Supports the QA Lead with audit activities as required.
Essential Knowledge & Experience:
- Profound work experience in a similar role within quality assurance in a global pharmaceutical organization in the region.
- Strong communication & collaboration, working cross-functionally within matrix structures
- Strong written and verbal communication in English.
Preferred Knowledge & Experience:
- GMP/GDP Auditing Experience
- Experience working with distribution partners across the Middle East Africa region
Educations/Qualifications
- Degree in Pharmacy, Chemical Engineering, Chemistry, or equivalent.
Additional information
- This is a permanent, full time position.
- The position is based at the T-MEA regional headquarters of Astellas Pharma in Istanbul.
- Residency in Turkey is required.
- This position follows our hybrid working model. Role is blend of work from home and a minimum 3 days in Istanbul office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
What We Offer
- A challenging and diversified job in an international setting.
- Opportunity and support for continuous development.
- Inspiring work climate.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.