Quality Partner

İşveren Bilgilendirmesi

We are looking for a dedicated Quality Partner to join our team at Roche Pharma.

In this role, you will play a crucial part in ensuring our operations maintain the highest compliance standards in line with cGxP guidelines, Roche Global Pharma Quality Systems, and the Turkish Ministry of Health regulations.

Key Responsibilities.

Maintain, update, and implement the local Quality Management System (QMS) in strict alignment with global Pharma Quality Systems (PQS).

Prepare, review, and update Quality Management SOPs and ensure Quality Agreements are properly established for suppliers and logistics service providers.

Plan, prepare, and execute internal process, warehouse, and vendor evaluation audits to ensure compliance with GMP-GDP, and ISO standards.

Develop formal reports, track CAPAs in collaboration with Subject Matter Experts (SMEs), and ensure the Affiliate remains fully compliant and inspection-ready at all times.

Lead the reporting, investigation, and follow-up of deviations via the global quality management system, keeping relevant stakeholders informed.

Coordinate with Regulatory, Supply Chain, and contracted warehouse to manage process change notices, product launches, or deregistrations, providing technical assessments and validation approvals.

Collaborate closely with warehouse personnel to develop validation/qualification strategies for new projects consistent with internal policies.

Maintain all documentation pertaining to the validation of equipment, utilities, and relevant systems for regulatory agencies.

Manage return and replacement decisions alongside Commercial Affairs and Supply Chain, reviewing control results to decide on repackaging or destruction.

Closely monitor temperature data for the finished goods warehouse and transport vehicles, investigate excursions, and orchestrate product recall or mock-recall protocols with Health Authorities.

Follow up on critical changes (such as manufacturing site or packaging updates) to maintain uninterrupted product supply.

Plan and prepare Operational and Strategic Management Review reports to present to senior management.

Define quality objectives to support the issuing of the Annual Affiliate Quality Action Plan, and act as a resource to provide functional guidance to colleagues with less experience.

Act as the responsible for the end-to-end processing of customer complaints and temperature excursions within the global QMS, including communicating with complainants, managing cross-departmental monthly reconciliations, and archiving required documentation.

The role involves investigating suspected counterfeits reported by patients, healthcare professionals, or health authorities, escalating confirmed cases and diversions directly to TİTCK while keeping global and local management informed.

Additionally, this position drives compliance across the network by delivering specialized complaint management, quality, and SOP training sessions to Roche staff and logistics service providers.

Deliver quality and SOP training to Roche staff and logistic service providers.

Requirements.

Bachelor's or Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field.

At least 5 years of experience in the pharmaceutical industry within GMP-regulated areas.

Strong knowledge of quality management systems (GCP, GDP, GMP, GVP), TİTCK guidelines, MDR, and ICH.

Familiarity with ATMPs and medical device regulations is highly preferred.

Full proficiency in both Turkish and English (written and spoken).

Çalışma Modeliİş Yerinde.

Lokasyonİstanbul +80 il daha.

Başvuru Kriterleri

• Eğitim SeviyesiÜniversite(Mezun)
• DeneyimTecrübeli / Tecrübesiz

Çalışma Düzeni

• Çalışma ŞekliTam Zamanlı