Senior Quality Assurance Specialist
vor 3 Monaten
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.
We are currently hiring a Senior Quality Assurance Specialist to join our team in Grossbeeren, Germany.
Main purpose of Job:
The role involves leading relevant sections of the Quality Management System (QMS) to implement and execute tasks relating to day-to-day Quality Assurance (QA) aspects, but also executing those tasks him/herself. The role entails taking responsibility for QA matters around processes and documentation and for the QA team under their responsibility and supervision.
Main Responsibilities:
Oversight of assigned Quality Management System areas that would also include but not be limited to:
- Lead, support, develop and mentor QA team members under their direct supervision.
- Implementation of the defined quality objectives for their QMS areas.
- Distribution, structuring and monitoring of quality tasks associated to QMS areas.
- Assist in the execution of tasks related to the daily aspects of QA department and QMS.
- Participation in customer meetings to discuss metrics or QMS aspects.
- Coordinates and assist with GMP internal audits.
- Coordinates and assists in the performance of external audits (e.g vendors, as required).
- Supports and assists with customer and regulatory audits and actions as required.
- Hosts/attends cross-departmental meetings as required acting as the quality representative.
- Control and further development of the QMS areas under their oversight.
- Supports tasks within wider QMS or business areas as required.
- Leads and supports relevant aspects of the QMS associated with management of changes, investigations, deviations, root cause analysis, CAPAs, risk assessments, qualification/validation, recalls and quality metrics as required by the business.
- Supports in the execution of training for quality & other relevant personnel.
- Undertakes and supports quality related tasks associated with strategic projects.
Qualifications and Experience:
- 5 Years’ Experience within a quality systems related role (ideally pharma related).
- Ideally 2 to 3 years experience of leading teams/people with experience in disciplinary processes.
- Demonstrable experience within Quality department, ideally in a packaging or pharmaceutical company.
- knowledge of packaging equipment, facilities and processes.
- To have good knowledge of Quality Assurance inspection requirements.
- Risk Analysis and Associated Methodology.
- Received formal training in GMP requirements from Quality Assurance.
- Fluent in business English and German.
- Good Interpersonal skills.
- Good written communication skills.
- Good numeracy / literacy.
- Good team skills.
- Technical aptitude.
- Strong commitment to Quality Assurance principles.
- Analytical approach / attention to detail.
- Professional.
- Self-motivated and organised.
- Persuasive.
LI-VR1
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._
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