Quality Systems Specialist

Recordati; Çerkezköy; On-site; TRY 300,000 - 420,000; Full time

Job summary

Recordati in Çerkezköy, Türkiye, seeks a Quality Assurance professional to execute GMP-compliant QA activities and validation projects. You will prepare and maintain QA documentation, participate in audits, and drive corrective actions in close collaboration with Manufacturing, Regulatory, and Procurement teams.

The role emphasizes continuous improvement, adherence to quality systems, and the development of a strong quality culture across the organization.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, or a related scientific discipline.
• 3-4+ years of Quality Assurance experience in the pharmaceutical industry.
• Strong knowledge of GMP regulations and quality documentation systems.
• Proficient in Microsoft Office applications.
• Analytical, systematic, and results-oriented mindset with strong teamwork and communication skills.
• Professionally proficient English is preferred.
• Completion of military service required for male candidates.
• Residing in or willing to relocate to Çerkezköy, Kapaklı, Çorlu or Ergene within a short time.

Responsibilities

• Execute Quality Assurance activities in compliance with GMP, Ministry of Health regulations, and company Quality Management System requirements.
• Plan, coordinate, execute, and document validation and qualification activities, including process, cleaning, and transportation validation.
• Prepare, review, maintain, and control quality documentation, including SOPs, protocols, reports, and related QA documents.
• Manage Change Control, Deviations, CAPA, Risk Assessment, and Quality Agreement processes, ensuring timely implementation and follow-up of required actions.
• Participate in internal, external, regulatory, and supplier audits, and support the implementation and monitoring of corrective and preventive actions.
• Coordinate supplier qualification activities and collaborate with cross-functional teams to ensure supplier compliance.
• Work closely with Manufacturing, Quality Control, Regulatory Affairs, and Procurement to ensure timely execution of Quality Assurance activities.
• Develop and monitor Validation Master Plans, oversee validation studies, and identify revalidation requirements.
• Deliver GMP and Quality Assurance training and support the development of a strong quality culture across the organization.
• Contribute to continuous improvement initiatives and support the achievement of quality and operational excellence objectives.

Skills

GMP knowledge

Quality documentation

MS Office

Analytical mindset

Teamwork & communication

English proficiency

Education

Bachelor’s degree in Chemistry

Bachelor’s in Chemical Engineering

Tools

QMS software

Job description

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

Job Purpose

Key Responsibilities

• Execute Quality Assurance activities in compliance with GMP, Ministry of Health regulations, and company Quality Management System requirements,
• Plan, coordinate, execute, and document validation and qualification activities, including process, cleaning, and transportation validation,
• Prepare, review, maintain, and control quality documentation, including SOPs, protocols, reports, and related QA documents,
• Manage Change Control, Deviations, CAPA, Risk Assessment, and Quality Agreement processes, ensuring timely implementation and follow-up of required actions,
• Participate in internal, external, regulatory, and supplier audits, and support the implementation and monitoring of corrective and preventive actions,
• Coordinate supplier qualification activities and collaborate with cross-functional teams to ensure supplier compliance,
• Work closely with Manufacturing, Quality Control, Regulatory Affairs, and Procurement to ensure timely execution of Quality Assurance activities,
• Develop and monitor Validation Master Plans, oversee validation studies, and identify revalidation requirements,
• Deliver GMP and Quality Assurance training and support the development of a strong quality culture across the organization,
• Contribute to continuous improvement initiatives and support the achievement of quality and operational excellence objectives.

Required Education

Required Skills and Experience

• Bachelor’s degree in Chemistry, Chemical Engineering, or a related scientific discipline,
• 3-4+ years of Quality Assurance experience in the pharmaceutical industry,
• Strong knowledge of GMP regulations and quality documentation systems,
• Proficient in Microsoft Office applications,
• Analytical, systematic, and results-oriented mindset with strong teamwork and communication skills,
• Professionally proficient English is preferred,
• Completion of military service required for male candidates,
• Residing in or willing to relocate to Çerkezköy, Kapaklı, Çorlu or Ergene within a short time.

Technical Competencies

Required Languages

Required Behaviours and Competencies

Travel required in %

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.