Stability Control Specialist

Viatris; Fatih; On-site; TRY 180,000 - 240,000; Full time

Job summary

Viatris is seeking a Stability Control Specialist to oversee stability testing in our Quality Control Laboratory. You will authorize results in LIMS, ensure adherence to cGMP/GLP and data integrity requirements, and coordinate sample pulls, timelines, and reporting deadlines.

The role requires strong analytical skills, experience with HPLC (Empower) and other instruments, and excellent communication in Turkish and English. Collaboration in a matrix environment is essential.

Qualifications

• Bachelor’s Degree in Chemical Engineering, Chemistry, Pharmacy or a related discipline.
• Min 2 years of experience in the Quality Control Laboratory in a Pharmaceutical Company.
• Solid knowledge of cGMP, GLP and Data Integrity requirements in the pharmaceutical environment.
• Excellent verbal and written communication skills both in Turkish and English, and able to work in a matrix environment.
• Experience with laboratory instruments and systems such as HPLC (Empower), UV, GC, Spectrophotometer, FTIR, Karl Fischer…etc.

Responsibilities

• Performing technical control of stability testing and authorizing in LIMS system in accordance with current specifications, approved procedures, cGLP, cGMP, EHS rules and data integrity approaches.
• Participate in performing stability and finished product testing as required.
• Assisting and following up Site Stability Program scheduling of sample pulls, testing timelines, and reporting deadlines.
• Performing and assisting labeling of the stability samples, checking the samples are correctly labeled and placed in correct chambers, checking the pulled samples are taken in correct amounts.
• Writing laboratory investigations / deviations and determining CAPAs.
• Preparing Stability related protocols, reports, trend reports, annual&monthly plans.
• Writing and updating SOPs related to Stability and laboratories when necessary, providing the necessary training.
• Writing and updating product specifications and test methods.
• Supporting LIMS administrative activities by promptly resolving issues to prevent any delays in product manufacturing or analysis approvals.

Skills

cGMP

Data Integrity

LIMS systems

HPLC (Empower)

Education

Bachelor's degree in Chemical Engineering

Pharmacy related discipline

Tools

HPLC (Empower)

UV

GC

Spectrophotometer

FTIR

Karl Fischer

Job description

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

• Access – Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
• Partnership – Leveraging our collective expertise to connect people to products and services.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference, and here’s how the Stability Control Specialist role will make an impact:

• Performing technical control of stability testing and authorizing in LIMS system in accordance with current specifications, approved procedures, cGLP, cGMP, EHS rules and data integrity approaches.
• Participate in performing stability and finished product testing as required.
• Assisting and following up Site Stability Program scheduling of sample pulls, testing timelines, and reporting deadlines.
• Performing and assisting labeling of the stability samples, checking the samples are correctly labeled and placed in correct chambers, checking the pulled samples are taken in correct amounts.
• Writing laboratory investigations / deviations and determining CAPAs.
• Preparing Stability related protocols, reports, trend reports, annual&monthly plans.
• Writing and updating SOPs related to Stability and laboratories when necessary, providing the necessary training.
• Writing and updating product specifications and test methods.
• Supporting LIMS administrative activities by promptly resolving issues to prevent any delays in product manufacturing or analysis approvals.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s Degree in Chemical Engineering, Chemistry, Pharmacy or a related discipline
• Min 2 years of experience in the Quality Control Laboratory in a Pharmaceutical Company
• Solid knowledge of cGMP, GLP and Data Integrity requirements in the pharmaceutical environment
• Excellent verbal and written communication skills both in Turkish and English, and able to work in a matrix environment.
• Experience with laboratory instruments and systems such as HPLC (Empower), UV, GC, Spectrophotometer, FTIR, Karl Fischer…etc.
• Good at teamwork and being team member and collaboration.
• Strong evidence of problem-solving/troubleshooting skills.
• Able to adapt to a dynamic work environment and adhere to tight deadlines.
• Able to meet requirements with frequent change, delays, or unexpected events. Displays original thinking and creativity; meets challenges with resourcefulness.
• Strong technical writing ability. Writes clearly and informatively, able to express complex ideas in a clear, concise manner.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris?

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility