Are you a QA Officer and looking for a job in an innovative pharmaceutical company?
As a QA Officer your tasks include:
- Responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
- This includes involvement in quality-related activities for computerized systems which are required by the Quality Manual or with potential for impact on product quality, patient safety or data integrity.
You’ll also be responsible for:
- Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
- Providing the independent quality approval of key qualification /validation documentation.
- Representing QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
- Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems
- Bachelor's degree. Preferably Information Technology, Engineering or equivalent.
- Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
- Experience in delivering validated IT solutions or an application support role.
- Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
- Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.
- Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
- Limited supervision required in day-to-day activities.
A great job opportunity at a large healthcare company.
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: firstname.lastname@example.org Kenmerk: 9007.