Qualified Person QP
Qualified Person QP
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
Qualified Person (QP) is required for the sterile manufacturing and packaging plant at Grifols Worldwide Operations (GWWO), reporting to the Technical Director.
To ensure that the requirements of cGMP are met at all times.
To carry out product release for sterile manufacturing and packaging activities which can include Quality batch documentation review and control, review and approval of controlled documents including batch records and SOPs, quality performance reporting and supporting KPIs. Support of investigations, complaints and projects.
The successful candidate will be a demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills capable to deliver to tight and often multiple deadlines in a dynamic, challenging work environment.
What your responsibilities will be
- Product release of sterile manufactured product
- Product release of packaged product
- QA approval of visual inspection of Aseptic Process Simulation (APS)/Media Fill and Albumin product bags
- Review and approval of Change controls, CAPA and deviations related to sterile manufacturing and Packaging activities
- Review and Approval of Batch records and SOPs
- Support product recall activities
- Approval of Product complaints investigations
- Daily briefing on Quality batch review/approval
- Support annual product quality reviews
- Support the process change control system
- Support the quality audit/inspection programmes
- Participate in self inspection program
- Process/product/system improvement projects
- Responsible for follow up corrective actions identified through the Deviation system
- Provide quality performance information as required
- Ensure regular Quality interaction with other departments within GWWO and Grifols sister sites
- Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
- GMP implementation and site-wide Quality Awareness
- Perform additional duties as assigned
- Act as a delegate for activities performed by the Technical Director
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Experience in sterile manufacturing
- Knowledge in microbiology
- Excellent English
- Excellent verbal and written communications
- Strong interpersonal skills to interact with all levels of personnel professionally
- Have a strong quality and compliance background in the pharmaceutical industry
- Demonstrated leadership skills with ability to motivate, guide, train, coach and develop colleagues
- Strong decision- making skills
- Ability to manage multiple projects to plan/budget
- Lead Auditor Certified
- Experience in using SAP
- Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems
- Experience Statistical Process Control (SPC)
- MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status
- Minimum of 8 years relevant pharmaceutical experience
- QP on-licence experience of minimum 2 years
What we offer
- It's a brilliant opportunity for someone with the right talents.
Information about Grifols is available at www.grifols.com. If you're interested in joining our company and you have what it takes, then don't hesitate to apply. Grifols is an equal opportunity employer.
We look forward to receiving your application.