QA Training & Compliance Coordinator

Central Pharma is a growing pharmaceutical organisation based in Bedford, with quality, compliance and continuous improvement at the heart of what we do.

We’re investing in our people, processes and systems as we continue to develop and grow. It’s an exciting time to join us, with opportunities to make an impact, influence change and help shape our future.

Job Description

QA Training \& Compliance Coordinator

Reporting to: Quality Director

Primary Objective

The QA Training \& Compliance Coordinator is responsible for coordinating and maintaining QA training and associated compliance across the organisation, ensuring employees receive appropriate GMP/GDP, SOP and Quality System training relevant to their roles.

The immediate priority of the role is to bring QA training records and requirements back into compliance, addressing current and historic gaps and establishing sustainable processes to maintain compliance going forward.

The role will coordinate training requirements, training populations, completion, records, effectiveness and compliance reporting, working closely with SOP Owners, Subject Matter Experts, managers and the Learning \& Development function.

The role will also play a key role in the identification, implementation and ongoing support of new Learning Management and electronic Quality Management systems, ensuring QA training, competency, compliance, record\-keeping and reporting requirements are effectively incorporated.

Wider organisational learning, employee development and strategic Learning \& Development activity sit outside the scope of this role and remain with the Learning \& Development function.

Key Responsibilities

QA Training Compliance \& Recovery

• Review the current QA training position and identify overdue, incomplete, missing or inadequately evidenced training.


• Develop and coordinate actions to bring QA training records back into compliance.


• Prioritise outstanding requirements according to quality and compliance risk.


• Work with managers, SOP Owners and SMEs to resolve identified training gaps.


• Establish sustainable controls to prevent future QA training backlogs.


• Monitor progress and provide regular compliance reporting to the Quality Director.

QA, GMP/GDP \& SOP Training

• Coordinate QA, GMP/GDP, SOP and Quality System training requirements across the organisation.


• Deliver or coordinate appropriate quality and compliance training.


• Review new and revised SOPs to identify associated training requirements.


• Determine appropriate training populations and the level of training required.


• Coordinate training within required implementation and compliance timescales.


• Ensure training content accurately reflects approved procedures and Quality System requirements.


• Work with SOP Owners and SMEs to ensure training is technically accurate and appropriate.

Training Matrices, Records \& Compliance

· Establish and maintain appropriate role\-based QA training matrices.

· Ensure training assignments reflect employees' roles and responsibilities.

· Review training requirements for new starters, role changes and changes to responsibilities.

· Monitor overdue and outstanding QA training and follow up as required.

· Ensure QA training records are accurate, traceable and appropriately maintained.

· Maintain appropriate QA training compliance metrics and reporting.

· Ensure training records remain readily available and inspection ready.

Training Effectiveness \& Competency

• Coordinate appropriate methods for assessing QA training effectiveness and competency.


• Develop or coordinate knowledge checks, assessments and practical competency assessments where required.


• Identify training or competency gaps and coordinate appropriate retraining.


• Review quality events, CAPAs, audit findings and trends where training or competency may be a contributing factor.


• Work with managers, QA and SMEs to address identified gaps.


• Ensure QA training focuses on appropriate understanding, application and competency rather than completion alone.

Quality Training Systems

• Identify and support the selection and implementation of a new Learning Management System (LMS), ensuring QA training, competency, record\-keeping and compliance reporting requirements are appropriately incorporated.


• Support the implementation and ongoing development of a new electronic Quality Management System (eQMS), working closely with internal stakeholders and external system providers.

· Define QA training, competency, record\-keeping and reporting requirements for relevant learning and Quality systems.

· Liaise with internal stakeholders, system users and external providers throughout system selection, implementation and ongoing development.

· Support system configuration, testing, User Acceptance Testing (UAT), implementation and migration of QA training and Quality records where applicable.

· Support the development and configuration of training matrices, workflows, compliance reports, dashboards and appropriate system controls.

· Coordinate user training arising from the implementation, rollout or change of learning and Quality systems.

· Provide ongoing support for relevant system processes and coordinate system changes where these impact QA training, compliance or Quality requirements.

· Work collaboratively with Quality, IT, Learning \& Development, managers, system users and external providers to support successful system implementation and adoption.

· Identify opportunities to improve the effectiveness, efficiency and integrity of QA training and compliance processes through the appropriate use of systems and technology.

· Strategic ownership of wider organisational Learning \& Development remains with the Learning \& Development function. QA retains responsibility for QA training requirements, training populations, Quality content, compliance expectations and competency requirements.

Audit, Inspection \& Continuous Compliance

• Maintain QA training documentation in a state of inspection readiness.


• Support internal, customer and regulatory audits relating to QA training and competency.


• Provide appropriate training records, compliance data and evidence when required.


• Support responses and CAPAs arising from training\-related audit or inspection findings.


• Identify recurring QA training issues and support continuous improvement.


• Escalate significant QA training compliance risks to the Quality Director.

Skills \& Competencies

Essential

• Good understanding of GMP/GDP, QA processes, Quality Management Systems and SOP requirements.


• Experience working within a regulated environment.


• Strong organisational and coordination skills.


• Excellent attention to detail and accuracy.


• Effective written and verbal communication skills.


• Ability to deliver and coordinate training across different functions.


• Ability to interpret procedures and communicate technical requirements clearly.


• Strong problem\-solving skills and the ability to identify compliance gaps.


• Ability to work collaboratively with managers, SOP Owners and SMEs.


• Good digital skills, including Microsoft Office.


• Ability to manage multiple priorities and compliance\-driven deadlines.


• Ability to work effectively with internal stakeholders and external system providers.

Desirable

• Pharmaceutical or similar regulated industry experience.


• Previous QA/GMP training or training compliance experience.


• Experience working with Learning Management Systems or electronic Quality Management Systems.


• Experience supporting the selection and implementation of LMS and/or eQMS platforms.


• Experience supporting system configuration, testing or UAT.


• Experience with system or training\-record migration.


• Experience developing compliance reports, KPIs or dashboards.


• Experience supporting audits or regulatory inspections.

Key Relationships

The role reports to the Quality Director and works closely across the business.

The role will liaise with external LMS/eQMS providers and other relevant third\-party partners during system selection, implementation, testing, rollout and ongoing development.

The role will collaborate with the Learning \& Development Coordinator where support with learning methodology, coordination or delivery is required. However, QA retains responsibility for determining QA training requirements, training populations, Quality content, compliance expectations and competency requirements.

Wider organisational Learning \& Development strategy, employee development and non\-QA learning remain the responsibility of the Learning \& Development function.

Success Criteria

Success in the role will be demonstrated through:

• QA training records being brought back into and maintained in compliance.


• Reduction and ongoing control of overdue or incomplete QA training.


• Accurate and effective role\-based QA training matrices.


• Timely training following new or revised SOPs.


• Accurate, traceable and inspection\-ready training records.


• Appropriate evidence of training effectiveness and competency.


• Effective QA training compliance reporting.


• Successful identification, implementation and adoption of a new Learning Management System, with appropriate QA training and compliance requirements embedded.


• Effective implementation and ongoing support of the eQMS, working collaboratively with internal stakeholders and external system providers.


• Effective configuration and use of systems to support training matrices, compliance reporting and appropriate controls.


• Effective support during audits and regulatory inspections.


• Sustainable controls that prevent recurrence of historic QA training gaps.


• Continuous improvement in the efficiency and effectiveness of QA training and compliance processes.

Pay: From £36,000\.00 per year

Benefits:

• Casual dress


• Company pension


• On\-site parking


• Referral programme

Applicati

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