Senior QC Validation Engineer - Analytical Methods \& GMP Compliance

Are you an experienced validation professional looking to work in a highly regulated and advanced pharmaceutical environment? At Halden Pharma, we are strengthening our QC Validation and Compliance team and are now looking for a Senior Validation Engineer / Specialist to play a key role in ensuring quality, compliance, and robustness of our analytical methods. This is a unique opportunity to join a specialized pharmaceutical manufacturing company where you will work closely with experts across QC, QA and production - and contribute directly to delivering medicines to patients. **About the role:** In this position, you will support the team within analytical method validation and play a central role in method transfers, implementation, and lifecycle management. You will work in a dynamic environment with a high level of cross-functional collaboration and exposure to both internal stakeholders and external partners. **Key responsibilities:** - 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 **Who we are looking for:** We are looking for someone who combines strong technical expertise with a pragmatic and collaborative mindset. **Qualifications:** - Bachelors or masters degree (or equivalent) in Chemistry, Pharmacy, Biotechnology, Microbiology or another related field - Several years of relevant professional experience in analytical method development, optimization, and validation within biotechnology, life sciences, diagnostics, pharmaceuticals, or a related field. - Experience with multiple analytical techniques - Knowledge of USP and Ph. Eur. is an advantage - Familiarity with regulatory guidelines such as ICH Q2 (R2), ICH Q14 and EU GMP Annex 1 are beneficial **Personal qualities:** - Structured and quality-focused, with the ability to manage complex tasks - Proactive and solution-oriented, with a drive to deliver results - Strong collaboration skills and ability to work across functions and cultures - Clear and confident communicator in English (written and verbal) - Takes ownership and demonstrates sound judgment within area of expertise **Why join Halden Pharma?** - Work in a highly competent and collaborative environment - Being part of a company with advanced manufacturing technologies and strong growth ambitions - Opportunity to influence and shape validation practices in a regulated setting - International work environment with exposure to global customers and partners **Om bedriften** Halden Pharma is a specialized pharmaceutical manufacturing company with advanced manufacturing technologies and strong growth ambitions. The company operates in a highly regulated and advanced pharmaceutical environment, emphasizing quality, compliance, and robustness in its processes. Halden Pharma fosters a highly competent and collaborative international work environment with exposure to global customers and partners.

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