Quality Assurance Specialist (M/F) Torres Vedras

Quality Assurance Specialist (M/F)
Torres Vedras
Torres Vedras, Lisboa, Portugal

Tecnimede Group is a Portuguese multinational company, with more than 40 years of history in the life cycle of the drug product for human use - development, production, promotion and marketing - with the mission to improve and preserve human life and health.

Exporting to more than 100 countries worldwide, it is present in 6 countries (Portugal, Spain, Italy, Morocco, Colombia, and Brazil) with a strong focus on expanding internationally and building strategic partnerships.

To strengthen our core team in Torres Vedras, we are looking for a Quality Assurance Specialist to join our company.

Basic Qualifications:

Bachelor’s degree and a minimum of 3 years of industry experience in a GMP regulated environment.

Preferred Qualifications:

• Validation experience (lab equipment or
  - related systems).
• Experience applying GMP and data integrity requirements in a QC setting.
• Strong level of analysis skills to evaluate and interpret data to arrive at logical and
  - minded conclusions.

Responsibilities (include but are not limited to):

• Authors and reviews SOPs and policies. Create and establish processes and procedures to ensure compliance and adherence to regulations and c
  GMP operations.
• Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations.
• Oversees execution of remediation/CAPA activities required to continue production, moving a process to the next milestone. Works closely with others to determine root cause and potential preventive/corrective actions. Ensure timely closure of investigations.
• Responsible for providing quality oversight to the change management system for change controls related to cell bank and cell vaccine manufacturing. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
• Ensures all specifications are met and that applicable requirements are completed and acceptable.
• Participate in quality oversight of testing, with
  - time observation of activities.
• Work closely with others to recognize opportunities for improvement and drive change through the use of Quality Systems.
• Participate in internal audits for compliance with SOPs, GMPs, and regulations.
• Perform other duties as assigned.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Quality Assurance

Industries: Pharmaceutical Manufacturing