Quality Assurance Technician

at  PCI Pharma Services

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main responsibilities:
Quality Assurance Technician provides administrative and technical support to the Quality Assurance team, preferably in qualification and validation.

Competence profile:

• Completed vocational training or bachelor’s degree in the pharmaceutical, scientific or technical field
• Good written and spoken German and/or English skills
• Good knowledge of MS Office (Excel, Word and Outlook)
• GMP knowledge or knowledge of comparable regulations is advantageous

Description of tasks:

• Creation of documents for qualification, validation and computer system validation in English and German.
• Execution of qualification and validation activities for equipment & systems and processes including temperature distribution measurements and evaluation and verification of documents.
• Participation in the preparation of risk analyses.
• Carrying out administrative work in the qualification/quality system, such as maintaining lists, folder structures, logbooks and managing the qualification test equipment.
• Interdepartmental communication and problem solving in due consideration of the European GMP guidelines.
• Draft, rework and review of SOPs, Work Instructions and forms.
• Assist in the coordination and review of deviations, requests for corrective and preventive actions (CAPAs) and the preparation of final reports.
• Assisting in coordination of the change control panel; following up on change control actions with respective action owners and ensuring timely completion
• Assisting in the preparation of monthly metrics.
• Undertake additional quality tasks as directed by Line Manager to support business demands.

Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture

• Creation of documents for qualification, validation and computer system validation in English and German.
• Execution of qualification and validation activities for equipment & systems and processes including temperature distribution measurements and evaluation and verification of documents.
• Participation in the preparation of risk analyses.
• Carrying out administrative work in the qualification/quality system, such as maintaining lists, folder structures, logbooks and managing the qualification test equipment.
• Interdepartmental communication and problem solving in due consideration of the European GMP guidelines.
• Draft, rework and review of SOPs, Work Instructions and forms.
• Assist in the coordination and review of deviations, requests for corrective and preventive actions (CAPAs) and the preparation of final reports.
• Assisting in coordination of the change control panel; following up on change control actions with respective action owners and ensuring timely completion
• Assisting in the preparation of monthly metrics.
• Undertake additional quality tasks as directed by Line Manager to support business demands