Stability Lab Specialist - Pharma QC & Compliance

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

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.