Quality Partner

What will you do?

As a Quality Partner you will assist the organization with initial compliance and ongoing preparation, and monitoring of conformance to established quality assurance processes and standards. Perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy them. Facilitate internal training on quality assurance requirements, processes, and procedures. May perform audits and support inspections.

Key responsibilities :

• Work in accordance with cGxP guidelines, the directives and regulations of

Turkish Ministry of Health and Roche Global Pharma Quality Systems, ensure

that Quality processes are carried out according to these rules.
• Keep the implemented Quality Management system up-to-date according to
Roche Global Pharma Quality System (PQS) and cGxP guidelines.
• As the key personnel appointed by the Turkish Medicines and Medical Devices
Agency (TİTCK), reviewing the documentation defined in the relevant batch
release procedures (transport temperature data, batch certificates, customs
records, certificate of compliance) and sending the scan of batch release
documentation of the IMPs to the Quality Excellence Lead for the final batch
release approval to finished goods using Roche release systems.
• Lead, manage or contribute to global, regional or local quality projects from
initiation to delivery, e.g. creating efficiencies within complaint handling
processes or streamlining and harmonizing quality assurance activities.

Ensure that projects achieve and maintain a consistent state of full compliance and
inspection-readiness at all times. Ensure that project steps are in alignment with
business objectives, on time, within budget and according to project standards
and specifications. Apply critical and analytical thinking, tools and own
judgement to solve problems and deliver innovative solutions.
• Report and follow up with the GMP-GDP related deviations via the global
quality management system. Inform relevant stakeholders about the outcome

and take necessary actions.
• Conduct CAPAs triggered from deviations, inspections, risk assessments and
follow up the actions in collaboration with Subject Matter Expert (SME).
Implement and maintain quality assessments for process change notices/orders.
These changes will include process improvements, product launches or
deregistrations, and changes in the warehousing or distribution activities.
Provide timely updates and follow up on open issues of all assigned changes.
Coordinate the interaction between departments like regulatory, supply chain,
contracted warehouse to ensure appropriate changes are documented. Familiar
with equipment, utilities and validation concepts.
• Enable performing the validation of equipment and other relevant systems in
collaboration with warehouse personnel. Develop validation strategies for new
projects that are consistent with validation policies and procedures. Provide
technical assessment and validation approval for process changes. Maintain all
documentation pertaining to validation with regulatory agencies. Work
independently, within guidelines and policies.
• Plan/prepare necessary quality activities for audit/inspection-readiness of the
Affiliate.
• Participate the supplier/logistic service provider audits and ensure that the
suppliers/logistic service providers are working in compliance with cGxP and
Roche Quality standards as well as according to the Quality Agreements. Prepare

the audit reports, report the outcome of the audits and track the implementation of CAPA’s.
• Prepare/update Quality Agreements required for the suppliers/logistic service
providers.
• Support planning and participate to the site self-inspections. Initiate CAPA’s
according to the findings and track the closure/implementation of CAPA’s.
• Review and approve qualification documents provided by suppliers/logistic
service providers.
• Follow the global and local procedures, prepare and update the Quality
Management SOP’s with this aspect, provide the applications to be compliant
with the related SOP’s.
• Perform quality trainings/SOP trainings to the related staff of Roche and Logistic

Service Provider and prepare training records.
• Implement risk assessment and risk management activities to all IMP quality
operations where necessary.

• Act as the deputy in the absence of Quality Lead & Responsible Person for
quality related tasks.

Who are you?

• Bachelor's or Master's degree in Pharmacy, Chemistry, Chemical Engineering or a related field.
• At least 2 years of experience in the pharmaceutical industry and in GMP
regulated areas.

• Knowledge of quality management systems (GCP, GDP, GMP, GVP) including
legal requirements including TİTCK GMP/GDP guidelines, MDR, ICH.
• Knowledge of global Health Authority regulations, pharmaceutical quality
systems and other standards relevant to Roche’s product portfolio (Medical
device Regulations, ATMPs would be preferred)
• Proficiency in Turkish and English language, including speaking, reading and
writing.

Why Roche?

At Roche, we believe in fostering a culture of learning, innovation, and collaboration. We offer an environment where you have the freedom to shape your role in a way that aligns with your strengths and ambitions. Diversity and inclusion are at the core of our identity, and we encourage you to bring your authentic self to work every day.

What do we offer?

• A dynamic and market-leading company with national and international career opportunities

• A chance to make a meaningful impact by improving the lives of patients worldwide

• An agile and people-focused work environment, where autonomy and decision-making are valued

• Opportunities for personal and professional growth, with Roche investing in your development

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.