Quality Compliance Specialist

PE Global are currently recruiting for a Quality Compliance Specialist for our client site in Sligo on a 6-month initial contract:

HYBRID - 3 DAYS ONSITE

To coordinate the development and maintenance of company's quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured meet requirements of end users, of regulatory authorities and of the company.

The Quality Compliance Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and requirements.

Responsibilities

• Supports coordinating the quality system, ensuring full compliance by all personnel with its requirements.
• Supports a Quality Risk Management approach for all site activities and participates during the coordination Risk Control Strategies (RCS) and FMEA activities as required.
• Auditing the quality system with other management personnel.
• Initiation and Completion of Quality related ERs as required.
• Providing quality guidance, support, and approval on all site/system validation activities.
• Ensuring that products manufactured at Ireland Pharmaceutical Operations meet requirements of end users, of regulatory authorities and of the company.
• Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings e.g., SPM.
• Monitoring quality performance and advising management personnel on major quality issues.Ensuring all plant personnel are fully aware of quality and cGMP requirements
• Implementation review for Policy documents
• Supporting all aspects inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
• This position is crucial in identifying any causes of non-compliance of the quality system while maintaining effective communication with all employees.
• Adheres to and supports all EHS & E standards, procedures, and policies.
• Responsibility for supporting the following activities (as assigned) within the Quality Department:
• The investigation of and coordination of exceptions by ensuring implementation of effective corrective / preventive action where necessary
• Product quality review activities
• Management of all technical agreements from initiation, review, approval, and storage
• The coordination and management of all track and trend activities to support manufacturing and QC
• Coordinating change control and Change plan activities
• Vendor evaluation, approval, re-evaluation
• Data gathering for Management Review
• Metrics gathering and reporting
• The evaluation of customer complaints
• Training of personnel
• Review and approval of quality and validation documents
• The drafting of CAPA plans in response to audit findings
• The drafting of quality plans to support quality improvement initiatives
• The tracking and implementation of CAPA tasks and quality plan tasks

Qualifications

• A Third level qualification in a science, quality, or relevant discipline. Job/Technical Skills
• A minimum of two years' experience in a quality role.
• A strong knowledge of regulatory requirements is required.

Cognitive/Business Skills

• Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
• Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
• Requires innovative thinking, where new and untested solutions are proposed, demonstrated, and implemented on a regular basis.
• Must be results driven and accountable striving to meet all targets and metric standards as set by site/department and division leaders.
• Requires total commitment to quality and maintaining a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic at all times.
• Strong communication skills both verbal and written are required for the execution of this role.
• Strong interpersonal skills are required.

Ownership/Accountability

• The position has a high level of autonomy and individuals are expected to work on their own initiative.
• Shows a high level of tenacity to ensure closure of issues and projects assigned.
• This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned, and resolved.
• This position impacts on product quality and technical performance as well as manufacturing operations.
• Demonstrates an ethos of Right First Time at all times.
• Ensuring team compliance to procedures, policies and guidelines ensuring

adherence with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines as all times.

Influence/Leadership

• Expected to influence area owners to ensure that appropriate CAPA's are assigned to audit findings.
• May be required to lead Cross Functional Teams on compliance initiatives.
• Provides guidance to suppliers as required to maintain a compliant efficient relationship.
• Provide technical leadership to functional areas and collaborates with key stakeholders.
• Is a site SME on compliance and provides guidance on same.

Decision Making/Impact

• Is responsible for ensuring compliant decisions are made on change controls and policy review.
• Expected to handle all day-to-day compliance issues/queries, however, if a major problem occurs, they will confer with relevant site personnel.
• Decision making within confines of agreed responsibility with Manager.

Supervision Received

• Individual is given the authority to carry out duties without close supervision.
• Reports to a Senior Compliance Specialist or a member Quality Leadership Team