MISSION OF THE ROLE

Provide support for the release of finished products from the production unit, ensuring their quality and efficacy in compliance with Good Manufacturing Practices (GMP) and the Group’s regulations.

MAIN RESPONSIBILITIES

Regulatory Compliance and Safet y

- Comply with labor, quality, environmental, and safety regulations.
- Apply HSE protocols, including the use of Personal Protective Equipment (PPE), occupational risk prevention measures, and compliance with legal authorization requirements .

Quality Managemen t

- Define Quality objectives together with the Production Unit (PCU).
- Create, review, and approve general quality procedures and ensure they remain current and effective.
- Approve manufacturing and packaging instructions.
- Manage deviations and investigations, as well as lead corrective and preventive actions (CAPAs).
- Participate in OOS (Out of Specification) and OOT (Out of Trend) investigations related to production.
- Prepare and coordinate RQN meetings when required.
- Monitor complaints and follow up on resulting actions.
- Participate in projects, validations, and qualifications.
- Collaborate in self-inspections and external inspections .

Daily Operation s





- Participate in Visual Management meetings with the production unit.
- Coordinate the daily work plan according to priorities.
- Monitor activities and manage operational issues .

Product Releas e

- Review release documentation (manufacturing and packaging records).
- Verify the closure of deviations prior to product release.
- Record relevant information in internal systems (e.g., LIMS/LUNA).
- Ensure compliance with GMP requirements, regulations, and quality standards .

Other Responsibilitie s

- Provide back-up support for technical control activities.
- Ensure the collection of samples and the proper management of the retention sample archive .

REQUIREMENTS

- Proven experience i n Quality Assurance within the pharmaceutical indust ry, ideally in a manufacturing environmen t.
- Bachelor’s degree in Pharmacy
- Master’s degree in Pharmaceutical Quality, Regulatory Affairs, or a related discipline is considered an asset.
- Practical knowledge o f pharmaceutical manufacturing processes.
- Experience working wit h QMS and LIMS syste ms.
- Knowledge o f ERP systems (SAP is considered an advantag e).
- Strong understanding o f GMP, ICH guidelines, and quality standards (ISO 900 1).

📌 Quality Assurance Specialist - Shop Floor (Riells y Viabrea)
🏢 Adamed Pharma
📍 Riells y Viabrea