QA Compliance Specialist

About Siegfried

Expect to grow, personally and professionally. At Siegfried, we offer exciting challenges and ample opportunities to showcase your talent. As a trusted and respected partner in the pharmaceutical industry, we maintain the highest standards in safety, quality, and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company where diverse perspectives and experiences unite in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions, offering long-term opportunities to grow and make an impact.

Your Role

We at Siegfried are looking for a QA Compliance Specialist to join our Quality department at the Masnou site on a 12-month fixed-term contract.

Main Responsibilities:

• Manage QA oversight for Engineering, Automation, Validation, and IT activities.
• Manage Change Control, Risk Assessment, and Computerized System Validation (CSV).
• Manage QA oversight for Data Integrity (DI) to maintain and increase DI culture at the site.
• Ensure continuous maintenance and update of the Quality Management System, managing and implementing EU and FDA regulations, ISO standards, and internal/external applicable regulations.
• Lead the Internal Audit Plan and/or participate in the site's Internal Auditor Team.

QA Oversight:

• Maintain effective support and oversight for IT, Automation, Engineering, and Validation activities related to Quality Systems processes (non-wise-batch related), ensuring compliance with applicable regulations, local, and global procedures.
• Review and approve (re)qualification and periodic review of processes, systems, and equipment.
• Ensure effective QA oversight for New or Program Projects as a Project Team Member, including reviewing and approving documentation related to process validation, deviations, change control, etc.
• Ensure QA oversight of Pest Control.

Data Integrity:

• Continuously improve Data Integrity knowledge and understanding at the site, acting as an SME for all DI-related inquiries.
• Ensure site support for DI topics during investigations and audits/inspections.
• Perform and lead the DI Plan, including DI communication and engagement.
• Report status periodically to the Quality Review Board.

Quality Systems:

• Ensure governance and compliance of quality systems such as Change Control and Risk Assessment, including appropriate handling with Customers.
• Serve as Local Key User for Trackwise (support end-users, manage new accesses, perform user periodic review, assess system changes) when appropriate.
• Coordinate and perform the Quality Management System review through the monthly Quality Review Board.
• Coordinate and perform KPI reporting monthly from the site to Corporate.
• Ensure external regulations, standards, and applicable guidelines are implemented locally on time. Evaluate new regulations and support SMEs in documenting implementation.
• Deal with external auditors/inspectors (Customers, Corporate, Health Authorities) when necessary.
• Ensure the continuous review and update of Quality Systems documents: Quality Manual, Site Master File (Memoria Técnica), Medical Devices File (DMF), Control Contamination Strategy (CCS).
• Create, coordinate, and ensure continuous review of Quality Plan execution at the site.
• Coordinate the Quality Manual implementation with all GxP documentation issued by Corporate.

Internal Audits:

• Set up an effective and efficient Internal Audit Program and ensure its timely implementation.
• Support the Internal Auditors Team by preparing audit dossiers, following up on audits, providing orientation, and consistent criteria.

Miscellaneous:

• Ensure the continuous review and update of procedures applicable to your activities.
• Ensure adequate regulatory compliance.
• Act as a QA approver or coordinator of Change Control/Event/Deviation in TW when applicable.
• Participate in the site's Internal Auditor Team when applicable.
• Maintain a high level of scientific knowledge in the pharmaceutical quality field, ensuring adequate training.
• Develop annual or exceptionally established objectives, ensuring alignment with Siegfried's goals.
• Contribute to creating a motivating work environment that promotes dedication and professional excellence within the entire team.

Your Profile:

• Education: University degree in Sciences.
• Languages: Fluent in English and Spanish (Catalan is a plus).
• Experience: 1 to 5 years of progressive experience in Quality Assurance and/or in a sterile manufacturing facility within the pharmaceutical industry. Familiarity with quality systems and production processes (GMP, GLP, FDA, ISO).

Your Benefits:

• Flexible schedule with start times between 7:30 and 9:30 a.m. and finish times between 4:00 and 6:00 p.m.
• Private health insurance
• Life and accident insurance
• Subsidized canteen
• Pension plan

About Siegfried:

Founded in 1873 in Zofingen, Switzerland, Siegfried has become a global network with 13 sites across three continents. With a team of over 3,800 highly trained professionals, we bring our pharmaceutical clients' innovations to industrial scale and manufacture safe medicines for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations currently capable of conducting the development and manufacturing of active pharmaceutical ingredients (APIs) and finished dosage forms under one roof. This unique combination of knowledge and expertise makes us the most trusted partner in the pharmaceutical industry.

Key skills/competency:

• Quality Assurance
• Compliance Specialist
• Pharmaceutical Industry
• Data Integrity
• Quality Management System
• Internal Audits
• Regulatory Compliance
• GMP
• FDA
• ISO Standards