Responsible person, quality controller and quality manager - dublin - united kingdom, northern ireland

responsible person, quality controller and quality manager

job profile: the 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 rp 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 rp 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 rp 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.

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;

plant hygiene

process validation

training

the approval and monitoring of suppliers of materials

the approval and monitoring providers of other gmp related outsourced activities

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

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

skill 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 w

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