Quality Compliance Coordinator (Temp.)

TR11 (FCRS = TR011) Sandoz Grup Sağlık Ürünleri İlaçları Sanayi ve Ticaret A.Ş.; Gebze; On-site; TRY 60,000 - 80,000; Full time

Job summary

TR11 (FCRS = TR011) Sandoz Grup Sağlık Ürünleri İlaçları Sanayi ve Ticaret A.Ş. in Gebze is looking for a quality manager to oversee GxP compliance and support quality management systems. The ideal candidate has QC/QA experience in the pharmaceutical or biotech industry.

You will manage audits, supplier agreements, and CAPA follow-ups while ensuring compliance with quality standards and regulatory requirements. Strong skills in GMP procedures and process optimization are essential for this role.

Qualifications

• Work Experience: QC/QA in pharmaceutical or biotech with environmental monitoring and cleanliness zones.

Responsibilities

• Manages quality aspects and projects within the area of responsibility.
• Ensures GxP conformity and compliance with Sandoz Quality Management Systems.
• Supports compliance activities including audits and training.

Skills

Action Oriented

Continuous Learning

Dealing With Ambiguity

GMP Procedures

Process Optimization

Quality Assurance (QA)

Quality Standards

Self-Awareness

Technological Expertise

Technological Intelligence

GxP

Industry Standards

Compliance Requirements

Job description

Job Overview

Manages quality aspects and projects within the area of responsibility. Ensures and supports overall GxP conformity and compliance with the Sandoz Quality Management Systems. Supports effective GxP compliance and/or audit activities, operations and systems to ensure compliance of business areas with the Sandoz Quality Manual and Policies, and all relevant GxP, legal and regulatory requirements.

Major Accountabilities

• Supporting all compliance activities including SQM, PQR, DMS, CHANGE, training, archiving, audits, and recall.
• Implementation of Quality Systems (incl. documentation management).
• Supplier management activities (agreements, oversight, audit).
• Preparation, support and coordination of CAPA/follow‑up.
• Audit and inspection preparation and support.
• Change control review/approval.
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID, etc.).
• Ensure process quality assurance according to regulations.
• QP declaration review and approval.
• KPI trending.
• Ensure applications, certificate maintenance, etc. to local HA.
• SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within the same HA jurisdiction / country.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

Key Performance Indicators

• Ensures planning and successfully supports PQR/APQR activities.
• Successfully carries out site qualification and validation activities (planning, advising, review).
• Supports the implementation of Quality Systems (incl. documentation management).
• Ensures local DI and eCompliance oversight (training, inspections, plan, risk ID, etc.).
• Ensures process quality assurance according to regulations.

Minimum Requirements

• Work Experience: QC/QA in pharmaceutical or biotech with environmental monitoring and cleanliness zones.

Functional Breadth Skills

• Action Oriented
• Continuous Learning
• Dealing With Ambiguity
• GMP Procedures
• Process Optimization
• QA (Quality Assurance)
• Quality Standards
• Self‑Awareness
• Technological Expertise
• Technological Intelligence
• GxP
• Industry Standards
• Compliance Requirements

Desired Skills

• Continued Learning
• Dealing With Ambiguity
• GMP Procedures
• Qa (Quality Assurance)
• Quality Control (QC) Testing
• Quality Standards
• Self‑Awareness
• Technological Expertise
• Technological Intelligence

Languages

• English