QA Doc Officer - Ensure Document Quality in a Leading Pharmaceutical Company!

About Us:
Halden Pharma is a forward-thinking pharmaceutical company dedicated to the production of sterile liquid medicines. As part of our ongoing growth and commitment to quality, we are looking for a dedicated and detail-oriented QA Doc Officer to join our team. This role will play a key part in ensuring seamless management of production documentation and compliance with internal and external quality standards.

Key Responsibilities:

• Oversee distribution and archiving of specifications, including updating the Master Batch Record (MBR)/code list, and Production Plan in accordance with L revisions, 03 specifications, and inputs from Regulatory, Supply Chain, and Project teams. Adhere to the change control process, project-based and address nonconformities as necessary. Update eDMS (Electronic Documentation Management Systems) procedures for QA documentation and manage approval processes and status changes in SAP.
• Print the daily operations of MBR and ensure that it is reviewed by the second controller for accuracy and compliance.
• Distribute watermarked paper to QC and TPN, and issue production documents to the production team in accordance with the production schedule.
• Support preparation of MBR and other relevant documentation for APR/AQR/PQR in collaboration with QA Regulatory Affairs.
• Provide training to personnel on eDMS within their area of responsibility when required.
• Administration, monitor, update and maintenance of eDMS, which includes tasks such as creating, archiving, and updating the system's structure.
• Manage user transitions by archiving employee profiles upon departure or facilitating departmental transfers as required.
• Provide support to users experiencing problems with documents in the system and actively contribute to both routine and incidental tasks so that the department can operate smoothly and efficiently.
• Follow up and perform relevant actions for eDMS activities in Trackwise, including deviations, changes in the MBR, etc.
• Ensure documentation is stored and archived in Tornado in accordance with archiving procedures and ensure compliance with best practices.
• Take on additional responsibilities as defined by the supervisor.

Qualifications:

• A bachelor's degree is required; however, relevant experience may compensate for the educational requirement.
• Experience in document control or a related field within a regulated industry (pharmaceuticals, medical devices, biotechnology, or similar).
• Working Experience with regulations: ISO 9001, ISO 13485, 21 CFR part 211.
• Knowledge of regulatory requirements, including GMP, GDocP, QMS systems.
• Proficiency in Tech-Savvy (words, excel etc.) and with good IT understanding.
• Ability to collaborate effectively across departments and communicate clearly.
• Fluency in English, both written and verbal; proficiency in Norwegian is a plus.

Personal Attributes:

• Demonstrates a proactive and detail-oriented approach to tasks, ensuring thoroughness and accuracy.
• Possesses strong analytical and problem-solving skills, with excellent organizational abilities and a keen attention to detail.
• Capable of managing multiple responsibilities and meeting deadlines in a fast-paced environment.
• Collaborates effectively with team members, leveraging diverse strengths to achieve shared goals.
• Exhibits a collaborative mindset and a willingness to take initiative in driving projects forward.

What We Offer:

• An opportunity to be part of an innovative and growing organization.
• A supportive and inclusive work environment.
• Professional development opportunities.

How to Apply:
If you are passionate about quality and documentation excellence and want to contribute to our mission, we encourage you to apply. Submit your CV and cover letter via our careers portal.

Join Halden Pharma and play a crucial role in shaping the future of pharmaceutical excellence!

Please contact Yasemin Akbaba if you have any questions related to the position.

Applicants will be considered on an ongoing basis.