Quality Control Data Review Technician

Bial; Trofa; On-site; EUR 32,000 - 52,000; Full time

Job summary

Bial is seeking a QA Data Review Specialist for the Quality Control Laboratory in Portugal. You will review analytical data, calculations, chromatograms and records to ensure GMP compliance and data integrity.

You will support investigations and batch release, contributing to continuous improvements within the lab. The role requires a degree in Pharmaceutical Sciences or related field and 2–3 years of QC lab experience, with hands-on HPLC experience and knowledge of GC, KF and dissolution

Qualifications

• Requires degree in Pharmaceutical Sciences, Chemistry, Biochemistry or related field.
• 2–3 years of QC laboratory experience in pharma.
• Hands-on analytical testing in GMP environment.
• Strong knowledge of GMP and Data Integrity principles.

Responsibilities

• Review analytical raw data, chromatograms, worksheets and lab records to ensure accuracy and traceability.
• Ensure records comply with GMP, pharma standards and internal procedures.
• Collaborate with analysts and supervisors for timely batch release.
• Support GMP implementation and continuous improvement in analytical review processes.
• Participate in audits and inspections and support Quality Control activities.

Skills

Data review

GxP compliance

Analytical mindset

Effective communication

Education

Pharmaceutical sciences degree or related field

Tools

HPLC

GC

KF

Dissolution testing

Job description

Join Our Mission to Improve Lives Worldwide

Perform analytical data review activities within the Quality Control Laboratory (routine analysis, stability and validations), ensuring the accuracy and integrity of raw data, analytical results and laboratory documentation, as well as its compliance with GxP requirements and internal procedures. Support laboratory operations through technical review and investigations, contributing to continuous improvement within the laboratory.

The Impact You’ll Make

• Review analytical raw data, calculations, chromatograms, worksheets and laboratory records generated by the Quality Control Laboratory;
• Ensure analytical records comply with GMP requirements, pharma standards, testing specifications and internal procedures;
• Perform data review of physicochemical analyses conducted on raw materials, packaging materials, intermediates and finished products;
• Verify the completeness, consistency and traceability of laboratory documentation before approval;
• Identify data discrepancies, deviations, out-of-trend and out-of-specification results, supporting investigations when required;
• Review and assess analytical results generated by HPLC and other laboratory techniques;
• Collaborate with laboratory analysts and supervisors to ensure timely batch release activities;
• Support the implementation and maintenance of Good Manufacturing Practices (GMP) and Data Integrity requirements;
• Contribute to laboratory continuous improvement initiatives and optimisation of analytical review processes;
• Participate in audits and inspections, providing support within the scope of Quality Control activities;
• Ensure compliance with Quality, Environmental, Health and Safety policies, standards and procedures;
• Collaborate in all team activities, as needed.

What You’ll Bring

• Degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or a related scientific field;
• Minimum 2 to 3 years of experience in a Quality Control Laboratory within the pharmaceutical industry;
• Hands-on experience performing analytical testing in a GMP environment;
• Mandatory experience with HPLC techniques;
• Experience in analytical data review activities (preferred);
• Experience with Gas Chromatography (GC), Karl Fischer (KF) and Dissolution testing (preferred);
• Strong knowledge of GMP requirements and Data Integrity principles;
• Strong analytical and attention-to-detail skills;
• Ability to work collaboratively and communicate effectively with cross-functional teams;
• Sense of responsibility, organisation and quality mindset;
• Good knowledge of English.

Create Your Path@Bial

“At Bial there is no such thing as "luck". There is commitment, dedication, and involvement with the Bial project and my team is part of this journey.”

Nuno Costa (Senior Manager Qualifications & Projects, Portugal)