Daniel Winer

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Quality Systems Manager

Ref #: TTP - QSM
Daniel Winer 16/08/2022
Location: Basildon, Hybrid Not Disclosed Basildon, Hybrid
Salary: up to £55,000 + Benefits £
Type: Permanent
Sector: Pharmaceutical
Specialisms: Leadership, Auditing, CAPA, Computer System Validation
Date: 16/08/2022
Quality Systems Manager

Our client, a fast-growing global pharmaceutical client with offices in the UK, and globally is currently looking for an experienced Quality Systems Manager to join its team.

The successful Quality Systems Manager should have experience of working within a pharmaceutical environment and will have demonstrable experience of taking responsibility for the design, implementation, and maintenance of pharmaceutical quality systems

You must be commutable to the client’s Basildon HQ, as the team is working in the office a couple of times per week with the rest of the working week spent at home.

To be considered for the Quality Systems Manager role you must have experience in the management of computer system validation as well as root cause analysis and CAPA, continuous improvement, people leadership, and auditing. You will also

· Be a Graduate in Pharmaceutical Science or equivalent (A Postgraduate Degree or Diploma in Pharmaceutical Science or equivalent would be considered an advantage but not essential)

· Have proven experience of CSV

· Have previous experience of facilitating Investigation and Root Cause Analysis.

· Possess experience of routinely preparing and approving validation Documentation

· Have good working knowledge of current good manufacturing practice, standard operating

procedures, EU GMDP guidelines, regulations, and ICH Guidelines

· Have had training and supervisory skills with the ability to influence, instruct and listen

· Have the ability to forge sound working relationships with others

· Have experience of a pharmaceutical business / environment

This is a key role in this organisation, and you will take the lead on the compilation, organisation, follow up and hosting of the company Management review processes and be able to highlight trends and areas of noncompliance and improvements initiatives and actions. You will also be asked to

· Be responsible for the continuous improvement and inspection readiness processes

· Provide first hand support in the preparation and hosting of external inspections.

· Be responsible for the preparation of BOH responses and the follow up of actions ensuring timely deliverables are obtained (In conjunction with Line manager and/or affiliates)

· Lead internal and external third-party inspections

· Provide direction and guidance to the QMS/compliance specialist team.

· Ensure that the quality system meets the regulatory and operational needs of the client

· Provide effective management of all the PQS activities, including setting & monitoring key performance indicators (KPIs) and to present these KPIs at the Quality review Meeting

· Ensure training requirements are specified for training of staff

· Lead Change controls as required

· Perform and/or delegate internal and external audits

· Ensure self-inspection schedule is planned/managed and individual internal audits are assigned, planned, executed, and closed accordingly

· Ensure PQRs are completed in line with the planned schedule

· Lead inspection readiness activities and actively support customer and regulatory audits

· Chair Change control, CAPA, Risk management, Recall committee meetings, as necessary

· Ensure External Stability is tracked to maintain compliance

· Ensure CSV validation responsibilities are maintained in line with Eudralex Annex 11 requirements

· Be the Subject matter expert for CSV to support customer and regulatory audits and act as the SAP and eQMS Quality system administrator ensuring compliance and governance activities are undertaken for SAP

· Document System Quality risk associated with the SAP project.

· Ensure that all work is performed in compliance with GMP, Health & Safety and internal standards and policies

This is a fantastic opportunity for those who are looking to progress their careers in Pharma and the role also comes with a competitive salary plus bonus and rewards package including holiday, health and wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

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