Quality Control Specialist

Sandoz; Gebze; On-site; TRY 180,000 - 320,000; Full time

Job summary

Sandoz is seeking an experienced QC/QA professional in Gebze, Turkey to lead CAPA definitions, KPI trending, and stability testing activities within a GMP environment. You will review analytical data for release, support site qualification, and ensure data integrity across testing processes.

The role requires 3-5 years in pharma analytics, collaboration across boundaries, and strong knowledge of GMP standards.

Qualifications

• 3-5 years of experience in Pharma/Manufacturing analytical lab.
• GMP environment or equivalent experience.
• Collaborative work across functions.

Responsibilities

• Review and approve analytical data and tests (analytical release).
• Manage CAPA, KPI trending and data integrity reviews.
• Perform stability testing planning and evaluation.
• Support site qualification and validation activities.
• Maintain and calibrate lab equipment and plan preparation.
• Monitor microbiological testing of materials and utilities.

Skills

CAPA definition

KPI trending

cGxP compliance

Data integrity

Analytical testing

Quality control

Trend analysis

Laboratory equipment

Microbiology QC

OOS handling

Job description

• CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) – protocol preparation, evaluation, report preparation.
• Reporting (Stability plan preparation, trend analysis, evaluation) -Performance of Stability studies, protocols and comparative reports for supplier qualification -Review and approval of analytical tests (analytical release) -Microbiological QC -Perform Microbiological testing of materials and utilities, environmental and personnel monitoring -Provide expert Support for site qualification and validation activities -Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification -Trending and analysis of KPI/KQI -Support sample planning and sampling execution -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
  

Major Accountabilities

• OOx/Deviation handling.
• CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) – protocol preparation, evaluation, report preparation.
• Reporting (Stability plan preparation, trend analysis, evaluation) -Performance of Stability studies, protocols and comparative reports for supplier qualification -Review and approval of analytical tests (analytical release) -Microbiological QC -Perform Microbiological testing of materials and utilities, environmental and personnel monitoring -Provide expert Support for site qualification and validation activities -Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification -Trending and analysis of KPI/KQI -Support sample planning and sampling execution -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

• The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times -Timely and GMP-compliant analysis & documentation of the results.
• Error rate: Number of OOS (analysis errors) related to the number of analyzes -No complaints about official inspections.
• Individual performance is assessed using the PMP performance dialog together with the manager
  

Minimum Requirements

Work Experience:

• Functional Breadth.
• 3-5years experience in Pharma/Manufacturing sector in analytical lab in.
• Collaborating across boundaries.
• A GMP environment/equivalent.

Skills

• Continuous Learning.
• Dealing With Ambiguity.
• Decision Making Skills.
• Gxp.
• Industry Standards.
• Laboratory Equipment.
• Laboratory Excellence.
• Quality Control (QC) Testing.
• Quality Control Sampling.
• Self-Awareness.
• Technological Expertise.
• Total Quality Management.

Languages

• English.