Documentalist

• Temporary contract of approximately 6 months.
• Joining an international pharmaceutical company that is a leader in its sector.
• Dynamic, innovative, and highly specialized work environment.
• Continuous training and learning opportunities within the Quality area.
• Participation in cross-functional projects and collaboration with multidisciplinary teams.
• Flexible hours and teleworking option.

If you are motivated to be part of an environment where quality, regulatory compliance, and continuous improvement are key, we will be delighted to meet you.

• University degree.
• Valuable: Degree or Licentiate in Chemistry, Pharmacy, Biotechnology, or related disciplines.
• Knowledge of GMP regulations applicable to the manufacturing of active pharmaceutical ingredients (API).
• Training in Occupational Risk Prevention and Environment.
• Proficiency in Microsoft Office, especially Excel.
• Minimum English level B2.

We are currently looking for a Documentalist to join the Quality Assurance team at our Celrà plant.

The selected person will be responsible for providing technical, administrative, and documentary support to the area, guaranteeing the correct management, control, distribution, and filing of GMP documentation, as well as its compliance with established regulatory and quality requirements.

Provide technical, administrative, and documentary support to the Quality Assurance area, ensuring the proper control, distribution, and filing of GMP documentation and documentation related to project management.

• Issue and manage controlled copies of procedures (SOPs), specifications, analytical methods, and other regulated documentation, guaranteeing the withdrawal and destruction of obsolete versions.
• Coordinate GMP document management, in both physical and electronic formats, ensuring the correct organization, filing, and traceability of documentation.
• Manage the exchange of documentation with clients and third parties, in coordination with the project teams.
• Participate in the preparation and editing of product data analysis reports throughout their lifecycle, such as: OOT, PQR, CPV.
• Provide support in internal and external audits from clients and regulatory authorities.
• Participate in the creation and updating of manufacturing master sheets within the corporate documentary systems.
• Provide support to the Quality Assurance team in the review of executed manufacturing documentation.
• Act as a Key User for the electronic document management systems.
• Collaborate in the management of the annual GMP training plan, monitoring training actions and maintaining the corresponding records.
• Provide support in the administration and maintenance of the electronic document management and training platforms.