Quality Assurance Specialist

vor 1 Woche

Dresden, Deutschland PCI Pharma Services Vollzeit

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 purpose of job:
To implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation.

Main responsibilities:

- Writes and reviews SOPs, Work Instructions and Forms.
- Coordinates and reviews deviations, Non-Conformance reports, Corrective and Preventive Action Requests and assists in the preparation of final reports for QP review.
- Coordinates the Change Control Board, follows up on change control actions with appropriate action owners and drives for on-time closure of actions.
- Performs quarterly Environmental monitoring
- Assists in the preparation of Product Quality Review reports
- Prepares Monthly Metrics.
- Completes complaints investigations and assist with close out of complaints.
- Responsible for executing training for quality & other relevant personnel.
- Coordinates GMP internal audits.
- Coordinates and assists in the performance of external audits (as required).
- Assists with preparation for customer/regulatory audits.
- Assists with audit requests during customer/regulatory audits.
- Prepares responses to customer audits.
- Hosts/attends cross-departmental meetings as required as quality representation.
- Identifies and supports opportunities for improving processes and or procedures.
- Undertakes tasks and manages specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.

Person Specification
- 2-3 Years’ Experience within a quality systems related role (ideally pharma related)
- 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

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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