Hp Halden Pharma

Halden

Christine Louise Østensvig

HR Business Partner

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:
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Lead method transfer, validation, verification and implementation within the QC Chemistry Laboratory
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Author, review and approve analytical methods and related documentation
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Review and approve specifications for raw materials and packaging materials in line with pharmacopeial and GMP requirements
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Collaborate with external laboratories, including contract setup and approval of transfer protocols and reports
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Prepare and approve key quality documentation (SOPs, protocols, reports, risk assessments, specifications)
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Ensure timely implementation of pharmacopeia updates and verification of compendial methods
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Support organization within analytical validation field providing scientific and regulatory expertise
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Execute change control, handle deviations and drive CAPA processes in line with the Quality Management System
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Represent the department in audits and interactions with customers and regulatory authorities
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Who we are looking for:
We are looking for someone who combines strong technical expertise with a pragmatic and collaborative mindset.
Qualifications:
<ul><li>
Master&#39;s degree (or equivalent) in Chemistry, Pharmacy, Biotechnology, Microbiology or other related field
</li><li>
Experience from Quality Control in the pharmaceutical industry
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Knowledge of USP and Ph. Eur. is an advantage
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Experience with multiple analytical techniques
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Familiarity with regulatory guidelines such as ICH Q2 (R2), ICH Q14 and EU GMP Annex 1 is beneficial
</li></ul>
 
Personal qualities:
<ul><li>
Structured and quality-focused, with the ability to manage complex tasks
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Proactive and solution-oriented, with a drive to deliver results
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Strong collaboration skills and ability to work across functions and cultures
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Clear and confident communicator in English (written and verbal)
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Takes ownership and demonstrates sound judgment within area of expertise
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Why join Halden Pharma?
<ul><li>
Work in a highly competent and collaborative environment
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Be part of a company with advanced manufacturing technologies and strong growth ambitions
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Opportunity to influence and shape validation practices in a regulated setting
</li><li>
International work environment with exposure to global customers and partners
</li></ul>

Senior QC Validation Engineer - Analytical Methods & GMP Compliance