QA Manager Permanent

Main purpose of job:

The role is to lead the Quality Assurance Team to implement and execute tasks relating to day-to-day Quality Assurance aspects, but also executing those tasks him/herself. The role entails taking responsibility for Quality Assurance matters around processes and documentation and for the team.

Main responsibilities:

· Leads and develops the Quality Assurance team as well; leads continuous improvement of processes and workflows within the team

· Writes and reviews SOP’s, Work Instructions and Forms.

· QC support for Clinical operations:

· Goods-in checks

· Goods-out

· 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 assists with close-out of complaints.

· Responsible for 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 client/regulatory audits.

· Assists with audit requests during client/regulatory audits.

· Prepares responses to client audits.

· Hosts/attends cross-departmental meetings as required as quality representation.

· Identifies and supports opportunities for improving processes and or procedures.

· Leads 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.

Specification:

· At least 5 Years’ Experience within a quality systems related role, preferably as a manger

· 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 German and English

· Very good Interpersonal skills

· Good written communication skills

· Good numeracy / literacy

· Very good team and leadership skills

· Technical aptitude

· Strong commitment to Quality Assurance principles

· Analytical approach / attention to detail

· Professional

· Self-motivated and organised

· Persuasive