CLINIGEN GROUP LTD

Job Title: QUALITY ASSURANCE MANAGER

Job Profile: This role will be responsible for:

The QA Manager (Responsible Person (RP)) is responsible for safeguarding product users by ensuring Good Distribution Practice (GDP) and minimising the risk of potential hazards in the supply chain. The role has a clear reporting line to the license holder/MD in order to carry out their duties. They will also have access to all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas to ensure the necessary standards are achieved. The role will have the authority to make decisions to ensure GDP compliance can be demonstrated and that all regulatory obligations are met. This role will also include responsibilities of a Responsible Officer and will ensure legal compliance and regulatory affairs at the Ireland facility in regard to controlled drugs handling. As a Quality Manager, the role shall also be responsible for ensuring that operations carried out within the Quality team are completed in accordance with the requirements of the GxP regulations and guidelines, Clinigen Quality systems, and industry standards. As a Quality Controller, shall maintain oversight of the GMP processes, outsourced activities and approval/rejection of starting materials/packaging materials/bulk products/finished products.

Business Unit/ Division: Quality

Reporting to: As per organisation chart

Direct reports: As per organisation chart

Key Responsibilities:

• Primary host for client audits and responsible for the tracking and management of client audit

actions

• To ensure that the provisions of the wholesale distribution authorisation (WDA(H)) are observed

• Supporting that an adequate quality management system is established and maintained

• Supporting the management of authorised activities and the accuracy and quality of records

• Maintaining oversight that initial and continuous training programmes are implemented and

maintained

• Co-ordinating and promptly performing any recall operations for medicinal products

• Maintaining oversight of the process to ensure that relevant customer complaints are dealt with

effectively

• Maintaining oversight of the process to ensure that customers and suppliers are approved

• Approving any subcontracted activities which impact upon GDP for the Ireland site.

• To oversee audit of the quality management system and ensure that self-inspections are

performed at appropriate, regular intervals following a pre-arranged programme and that any

necessary corrective measures are put in place

• Keeping appropriate records of any delegated duties.

• Deciding on the final disposition of returned, rejected, recalled, damaged or falsified products

• Responsible for ensuring that there is full compliance with the statutory requirements of:

• Misuse of Drugs Act 1977 as amended,

• The Misuse of Drugs Regulations 1988 and any other associated applicable

regulations/amendments

• Compliance with EU Falsified Medicines directive (Directive 2011/62/EU)

• The conditions on any license that may be issued, and that there will be in place written operating

procedures that should be available on request by the Relevant Regulatory Authority.

• Evaluate the information in the eQMS for trends and initiate continuous improvements as required

• Support implementation of improvements to the electronic quality management system (eQMS) as

required

• Perform user acceptance testing for changes to the electronic quality management system as

required

• Review and approve Quality Technical Agreements relating to Good Distribution Practice (GDP)

• Ensure that appropriate standards of Good Manufacturing Practice (GMP)

• To manage authorised activities to ensure operations do not compromise the quality of medicines

and can demonstrate compliance

• Demonstrate the application of activities and provision in accordance with the Clinigen licenses

• Maintain awareness of issues surrounding falsified medicinal products

• Identify and support the implementation of improvement opportunities, collaborating with the

business areas, to form a strong and effective operational excellence team dynamic

• Maintain Clinigen paper and electronic records for quality documentation

• Maintain good working knowledge of continuous improvement tools and methodologies

• Take ownership to pro-actively develop your own capability and learning journey

• To manage quality personnel, ensuring job descriptions, objectives, personal development plans

and appraisals are up-to-date and completed on time

• To ensure that personnel are GxP trained and reflect the same within their duties

• To maintain training records for self and quality, to ensure training is assessed where required

Quality Controller key responsibilities include:

• Approving or rejecting, as they see fit, starting materials, packaging materials, and intermediate, bulk and finished products.

• Evaluating batch records.

• Approving specifications and sampling instructions and other quality control procedures.

• Ensuring the qualification and maintenance of their department, premises and equipment.

• Ensuring that the appropriate validations are done.

• Ensuring that the required initial and continuing training of their department personnel is carried out and adapted according to need.

• The authorisation of written procedures and other documents, including amendments.

• The monitoring and control of the manufacturing environment; o Plant hygiene o Process validation o Training o The approval and monitoring of suppliers of materials o The approval and monitoring providers of other GMP related outsourced activities o The designation and monitoring of storage conditions for materials and products. o The retention of records

• The monitoring of compliance with the requirements of good manufacturing practice

• The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality

• Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement

• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management

Leadership:

• Build and manage a high-performing, collaborative team that works in line with the Group’s values at all times

• Ensure the appropriate level of resource and expertise is in place and that this is structured in the most effective way to deliver the strategy

• Ensure that team have clear objectives (Performance and Personal Development) in place and regularly reviewed to ensure alignment with the KPIs and the divisional and Group level strategy

• Provide regular feedback to direct reports. Proactively address underperformance

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

• Recognise and celebrate success on a team and individual level.

• Operate in the role according to the Clinigen Values and lead by example.

People Development:

• Keep up to date with Good Distribution Practice guidelines

• Keep up to date with continuing professional development (CPD) as relevant to the position and role

• Continue to develop own talents and strengths and address any areas of self-development Role Requirements:

• Evidence of being able to build relationships with key internal and external customers

• Ability to work with tight deadlines in a dynamic environment, delivering high quality outputs with strong attention to detail

• Prioritisation and time management skills

• Pharmacy degree or minimum of one-year experience on a licensed wholesale dealing site

• Demonstrable experience of working within a quality assurance role, or other related role (essential)

• In order to effectively discharge their duties, the Responsible Person should have a basic knowledge of:

• EU legislation (EudraLex)

• Directive 2001/83/EC (as amended) of the European Parliament and of the Council of 6 November 2001 on the Community code Relating to Medicinal Products for Human Use

• The Human Medicines Regulations 2012 as amended

• Current Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/c 343/01)

• Demonstrable business and commercial awareness

• Effectively able to utilise a range of IT skills

• Able to handle multiple responsibilities, priorities and tasks

• Demonstrable reasoned logic to decision making and ability to recommend solutions in complex situations

• Adaptable to changing situations, with a proactive positive, flexible, assertive, can-do attitude

• Good influencing and stakeholder management skills

• Strong written and verbal communication skills

• Able to influence and lead by example, clearly communicating plans and results, promoting ownership and encouraging a collaborative approach to achieve solutions

Additional Duties: The list of duties 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 in many circumstances, 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. 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. In connection to 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 aware of any unsafe practice or condition, or if 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 to 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 to operate any plant or equipment unless authorised

• To report any accident, near-miss, dangerous occurrence or dangerous condition to their Line

Manager

• To switch off and secure unattended plant or equipment

• To avoid improvised arrangements and suggest safe ways of eliminating hazards

• Not to participate in horseplay or place fellow employees in danger by their actions

General Responsibilities:

• Champion the Clinigen Way principles which underpin everything we do, living those values in daily

Clinigen life

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, in many circumstances,.

Declaration: I have received, reviewed and fully understand the job description for this post. I further understand that I

am responsible for the satisfactory execution of the responsibilities described therein, under any and all

conditions as described. I understand that my responsibilities may change on a temporary or regular basis

according to the needs of my location or department without it being specifically included in the job

description.

Employee Name: ……………………………………………………. Employee Signature: ……………………………………………………. Date: ……………………………………………………. Managers Name: ……………………………………………………. Managers Signature: ……………………………………………………. Date: …………………………………………………….