Senior QC Validation Engineer: Methods & Compliance

Vagomet Oy | Go On Hämeenlinna; Berg; In loco; NOK 900.000 - 1.150.000; Tempo pieno

Descrizione del lavoro

Halden Pharma is seeking a Senior Validation Engineer / Specialist to join the QC Validation and Compliance team in Norway. You will lead method transfers, validation activities, and lifecycle management of analytical methods, while collaborating with QA, production, and external partners to ensure compliance and robust results.

The role requires a strong technical background in analytical method validation, familiarity with ICH Q2, Q14 and EU GMP Annex 1, and excellent English communication.

Competenze

• Bachelors or masters degree in Chemistry, Pharmacy, Biotechnology or related field.
• Several years of experience in analytical method development, optimization and validation.
• Experience with multiple analytical techniques and regulatory awareness (ICH, EU GMP).

Mansioni

• Lead method transfer, validation, verification and implementation within the QC Chemistry Laboratory.
• Author, review and approve analytical methods and related documentation.
• Collaborate with external laboratories, including contract setup and approval of transfer protocols and reports.
• Prepare and approve key quality documentation (SOPs, protocols, reports, risk assessments, specifications).
• Ensure timely implementation of pharmacopeia updates and verification of compendial methods.
• Support organization within analytical validation field providing scientific and regulatory expertise.
• Execute change control, handle deviations and drive CAPA processes in line with the Quality Management System.
• Represent the department in audits and interactions with customers and regulatory authorities.

Conoscenze

Analytical method validation

Cross-functional collaboration

Regulatory awareness

English communication

Formazione

Bachelor's or Master's in Chemistry/Pharmacy/Biotechnology

Descrizione del lavoro

Halden Pharma is seeking a Senior Validation Engineer / Specialist to join the QC Validation and Compliance team in Norway. You will lead method transfers, validation activities, and lifecycle management of analytical methods, while collaborating with QA, production, and external partners to ensure compliance and robust results.

The role requires a strong technical background in analytical method validation, familiarity with ICH Q2, Q14 and EU GMP Annex 1, and excellent English communication.