Quality Manager Aseptic Services

Quality Manager Aseptic Services

Key Responsibilities: 

Quality Management:

Salary: Circa £55k

Hours of work: On shift – 06.00 – 15.00 and 14.00 – 23.00

Follow, promote, and enforce relevant SOPs, Job Aids, and Company policies and procedures.

Ensure that all QPL licences and authorities are maintained and act as the key contact for the MHRA and Home Office.

Lead and close any audits performed by the above authorities, or per customer/client.

Lead and mentor the direct reports listed above.

Monitor and investigate trends in quality KPI’s namely fails, rework and complaints and report to the Board.

Lead a culture of continuous quality improvement by constant monitoring and review of the Quality Management System.

Promote and educate colleagues in GMP and GDP.

Personally act as Quality authorisation, sign off in conjunction with the Quality Director.

Develop a strategy for the Quality Department with the Executive Directors to ensure continuous regulatory compliance whilst supporting business development and meeting board objectives.

Provide Aseptic Quality input into the Management Review; ensuring outstanding issues are actioned and resolved, reporting to the Board if necessary.

Provide quality information to other departments as required for new customer business, product, and service tenders.

Lead, develop, and promote the change management system within QPL including any validation requirements arising.

Be able to act as a principal signatory for release of aseptically manufactured products.

Proactively support the business’ operation by helping in other departments which may be busier than your own at a particular time.

Shared responsibilities with Production Manager:

The authorisation of written procedures and other documents including amendments.

The monitoring and control of the manufacturing environment.

Plant hygiene.

Process validation.

Training.

The approval and monitoring of suppliers and materials.

The approval and monitoring of contract manufacturers.

The designation and monitoring of storage conditions for materials and products.

The retention of records.

The monitoring of requirements with the compliance of GMP.

The inspection, investigation, and taking of samples to monitor factors that may affect product quality.

Business Management: 

Regularly review and monitor top line operational performance and general business issues in conjunction with the other Managers and Executive team.

Support other key functional areas within the business as required.

Continuously develop departmental systems to improve efficiency and best use of resources.

As part of the senior management team, proactively review existing company policies and develop new ones to meet the needs of the business.

Ensure an effective communication cascade is established and maintained for all levels of information to be disseminated throughout the Quality team.

Develop and maintain a departmental staffing grid and effectively plan recruitment and working hours to avoid short-staffed situations.

Prepare and manage departmental budget and spending.

Translate new business opportunities into active projects, subject to board approval.

Deputise for the Quality Director, particularly with external stakeholder relationship building.

Definitions:              

GMP=Good Manufacturing Practice

GDP=Good Distribution Practice

KPI=Key Performance Indicator

People Management:  

Build and manage a high-performing, collaborative, team that always works in line with the Group’s values.

Ensure the appropriate level of resource and expertise are in place and that these are structured in the most effective way to deliver the strategy.

Ensure that the team have clear objectives in place and that they understand how these relate to the KPIs and the divisional and Group level strategy.

Ensure all team members have development plans in place and regularly reviewed.

Provide regular feedback to direct reports. Proactively address underperformance.

Ensure effective communication of key messages to the team from across the Group.

Identify top talent and ensure there is a plan in place to retain them, keep them engaged, and maximize their potential.

Recognise and celebrate success on a team and individual level.

Health and Safety Responsibilities:

The Management of Health and Safety at Work Regulations 1992 re-enacts the Health and Safety at Work etc. Act 1974, which places responsibilities on the employer and employees alike. With this, the Company reminds employees of their duties under Section 7 of the Act: 

To take care for their own health and safety and that of others who may be affected by their acts or omissions. Additionally, employees must also co-operate with the company to enable it to discharge its own responsibilities successfully.

Furthermore, all employees must: 

Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with safety rules/procedures, regulations and codes of practice.

If they become aware of any unsafe practice or condition, or if they are in any doubt about the safety of any situation, consult their Line Manager.

Obtain and use the correct tools/equipment for the work and not use any that are unsafe or damaged.  All tools, equipment, and personal protective equipment must be stored in the approved place after use.

Ensure that all guards are securely fixed, and that all safety equipment and personal protective clothing/equipment provided are used.

Not operate any plant or equipment unless authorised.

Report any accident, near-miss, dangerous occurrence, or dangerous condition to their Line Manager.

Switch off and secure unattended plant or equipment.

Avoid improvised arrangements and suggest safe ways of eliminating hazards.

Not participate in horseplay or place fellow employees in danger with their actions.

Responsibilities for Managers:

Each Manager is responsible for their personal safety and that of all personnel under their authority, including others who may be affected by the Company’s activities.

Be responsible for ensuring that the work under their control complies with all relevant health and safety legislation.

Demonstrate, promote, and encourage positive attitudes and behaviors to develop and maintain a positive safety culture.

Ensure that equipment is maintained in a condition safe to be used, and if not, prevented from being used.

Ensure that staff are aware of the emergency procedures.

Ensure that safe systems of work (SOPs) are in place and that these are recorded and communicated as required.

Ensure suitable and sufficient Risk Assessments are in place for tasks within their department, which pose a significant risk, and that these are recorded and communicated as required and ensure suitable control measures are devised and implemented.

Where responsibility is assigned to Supervisors/Team Leaders for specific areas, ensure there is a clear understanding of their specific duties and responsibilities.

Ensure all accidents, incidents, and hazards are reported to the local Health and Safety Manager and investigated where necessary.

Manage the provision of additional measures to protect employees with additional safety or health factors, such as young, pregnant, nursing, ill, or injured.

Provide staff with such information, instruction, supervision, and training to enable them to safely carry out their duties.

Ensure work areas are regularly inspected and monitored for unsafe conditions.

Ensure all contractors, before being appointed, are properly vetted, and have suitable and sufficient safety systems in place, coordinating these with the organisation’s own where required.

General Responsibilities:

Champion the principles which underpin everything we do, upholding those values in daily life.

Know company strategy and ensure what you do on a day-to-day basis is in line with those strategic objectives.

Ensure the work you do is of high quality and company standards, procedures and policies are always followed.

Engage in personal professional development and attend mandatory training.

Always present the Company in a positive way with internal and external clients, customers, and staff.

Always comply with the Company’s HR policies and the Health and Safety policy.

Work flexibly and efficiently to meet internal and external customer needs, whilst maintaining the highest possible professional standards.

Bring new ideas and approaches with an open mind.

Always maintain confidentiality and security.

Additional Duties/Responsibilities:

The list of duties/responsibilities is not intended to be exhaustive but gives a general indication of the tasks involved. It is the nature of the company that tasks, and responsibilities are, at times, unpredictable and varied.  All employees are therefore expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded.

Role Requirements:

Experience of operating in a similar role is essential.

Experience working within a licensed facility or under a section 10 exemption.

A formal qualification in science would be an advantage but not required. 

Demonstrable experience of working autonomously and making decisions.

A recognized management qualification is desirable although not essential depending on experience.

Strong, up to date, knowledge of Good Manufacturing Practices.

Confidence dealing with managers and employees at all levels.

Experience working in pharmaceutical/healthcare/life sciences industry is advantageous.

English and Mathematics GCSE grades A-C (or equivalent).

High computer literacy; experience operating with all Microsoft Office software.