Senior Quality Control Specialist

Sandoz; Gebze; On-site; TRY 150,000 - 300,000; Full time

Job summary

A global pharmaceutical company is seeking a quality assurance professional in Gebze. The role involves overseeing production and testing activities, ensuring compliance with cGxP, and executing batch releases. Ideal candidates will have experience in the pharmaceutical industry with a focus on quality standards and continuous improvement. Strong skills in quality control and assurance are essential.

Qualifications

• Experience in QC/QA in the pharmaceutical industry or biotech with environmental monitoring.
• Functional breadth across quality control and assurance processes.

Responsibilities

• Oversight of all production and testing activities.
• Ensure compliance with cGxP, including data integrity and eCompliance.
• Support exception investigations and review production records.
• Reporting of technical complaints related to products.

Skills

Continuous learning

Dealing with ambiguity

GMP procedures

QA (Quality Assurance)

Quality Control (QC) testing

Quality standards

Self-awareness

Technological expertise

Technological intelligence

Job description

Major accountabilities

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance; support exception investigations; review and approval of production, QC, and AS&T records; MBR review; support OpEx improvement projects; Qualified Person – executes batch release in compliance with registration; 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

• On-time and GMP-compliant release of dosage forms.


• No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.


• Successfully support continuous improvement projects.


• Executes batch release in compliance with registration.

Minimum Requirements

Work Experience

• Functional breadth.


• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.


• Collaborating across boundaries.


• cleanliness zones.

Skills

• Continuous learning.


• Dealing with ambiguity.


• GMP procedures.


• QA (Quality Assurance).


• Quality Control (QC) testing.


• Quality standards.


• Self-awareness.


• Technological expertise.


• Technological intelligence.

Languages

• English.