Quality Assurance Specialist
Division / Section:
Quality Assurance Manager
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.
· Writes and reviews SOPs, Work Instructions and Forms.
· QC support for Clinical Operations:
· Goods-in checks
· QA support for deviations etc.
· 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 cGMP 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.
· 2-3 Years’ Experience within a quality systems related role.
· Demonstrable experience within Quality department in a packaging or pharmaceutical company.
· High level knowledge of packaging equipment, facilities and processes.
· To have good knowledge of Quality Assurance inspection requirements.
· Good working knowledge of cGMP
· QMS Experience
· Risk Analysis and Associated Methodology
· Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
· Formally qualified to Degree level in an Engineering or other scientific discipline
· Received formal training in cGMP 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
· Self-motivated and organised