Quality Assurance Specialist - Turkey-MEA
About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity:
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 to 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 requires a blend of home and a minimum 3 days in our Istanbul office. Flexibility may be required in line with business needs. 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.