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Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Ringaskiddy, Cork, Ireland
Job Description:
POSITION SUMMARY:
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Sciences Ireland (JSI) UC as required by Good Manufacturing Practice (GMP).
These activities include, but are not limited to, operations on the floor support, change control, nonconformance investigation, quality systems auditing, supplier qualification, documentation management, incoming materials release, batch release, and annual product review and validation compliance activities at JSI.
NOTE: This role is 100% on-site. No hybrid working is available for this role.
This is a 4-Cycle Shift Role.
GENERAL SCOPE OF RESPONSIBILITIES:
- Provide routine QA presence in manufacturing areas during operations (50% of role) including:
- Ensure manufacturing activities are conducted in compliance with GMP requirements, site procedures, and regulatory expectations.
- Perform GMP walkdowns and ensure compliance with approved procedures and quality standards.
- Provide independent quality decision-making to support compliant production.
- Ensure manufacturing areas are in an audit-ready state
- Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
- Supports the development and management of GMP compliance systems through the following activities:
- Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
Carries out tasks related to the administration of site nonconformance management systems:
- Reviews and/or approves nonconformance investigations and their associated documentation.
- Manages entry of nonconformance records into the appropriate electronic system.
- Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
- Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
- Approves closure of nonconformance investigations on completion of the investigation and associated corrective actions.
Carries out tasks related to the management of site change control systems:
- Reviews and/or approves change control requests, implementation actions, and request closures.
- Manages entry of change control records into the appropriate electronic system.
- Tracks records from the initiation through closure processes and advises relevant personnel on the status of change requests and associated action items, as appropriate.
- Coordinates and chairs meetings of the site change control board. Sets meeting agenda and maintains meeting records.
- Approves closure of change requests on completion of related actions.
- Liaises with global quality systems change control representative to ensure change controls with global impact are appropriately managed.
Supports system qualification and process validation activities:
- Review and approval of qualification/validation documentation.
- Partners with relevant departments to develop and manage procedures to support qualification and validation activities.
Carries out administration of the electronic NC/CAPA management system:
- Manages the addition of new site users to the system.
- Provides training and support to users on the system.
- Participates in upgrade activities of the system as appropriate.
- Generates reports and metrics from the system as required.
Supports the development and management of document management systems which can include:
- Administration of the Electronic Document Management Systems at the site
- Develops and applies systems and procedures related to the Electronic Document management System at the site
- Carries out tasks related to the management of document control in respect of SOPs and other GMP regulated documents
- Supports and advises Documentation Control administration personnel, as required
- Provides training and support to users.
- Generates reports and metrics from the system as required.
Support the Auditing and Inspection Readiness Systems at the site:
- Supports execution of internal and external audits of the quality systems
- Reviews and approves proposed corrective actions arising from internal and external audits to provide assurance that deficiencies are adequately addressed.
- Tracks and monitors implementation of corrective actions to provide assurance that deficiencies have been corrected.
Supports GMP training activities:
- Partners with Training to assist in the development of training materials for provision of GMP training to site personnel.
- Provides training in compliance systems and GMP (i.e. as Subject Matter Expert) to site personnel as directed by QA/QS leadership.
Carries out tasks related to the administration of site supplier approval systems:
- Reviews documentation and test results, where applicable for all incoming QA released materials
- Reviews and/or approves supplier nonconformance.
- Works with logistics team to ensure all supplier and materials are qualified in accordance with applicable site and global processes.
- Supports the development of raw materials and components specification and co-ordinates the approval of these specifications via the applicable process.
Carries out tasks related to the management of batch records design and release systems:
- Reviews and/or approves all completed batch records in accordance with site procedures
- Releases all batches on SAP in accordance with site procedures
- Participates in the review process for master batch records.
- Liaises with QA at other sites to supply release data for JSI products.
Supports system process support validation and process validation activities:
- Review and approval of validation documentation.
- Partners with DPDS and Validation team to develop and manage procedures to support validation activities.
Carries out administration of the SAP Quality Management Module:
- Manages the addition of new site users to the system.
- Participates in upgrade activities of the system as appropriate.
- Maintains the quality module master data and associated system procedures
- Generates reports from the system as directed by the QA Team Lead / Manager
Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.
Deputises for the Quality Assurance Team Lead as appropriate.
KEY COMPETENCIES REQUIRED:
- Strong ability to make independent quality decisions
- Visible leadership presence on the manufacturing floor
- Excellent interpersonal skills
- Ability to operate as part of a team is critical.
- Customer focus
- Innovative
- Excellent communication skills both written and verbal
- Attention to detail
- Strong problem solving and critical thinking skills
- Results and performance driven
- Adaptable and flexible
QUALIFICATIONS AND EXPERIENCE:
ESSENTIAL- Quality Assurance Specialist-QA Operations (Shift):
- Bachelors Degree in a scientific/technical discipline required
- A minimum of 3 – 5 years experience in a quality, manufacturing, validation or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, HPRA, EMEA and other authorities.
DESIRABLE:
Previous experience in a shift role
KEY INDIVIDUAL CONTRIBUTOR COMPETENCIES:
- Thinks strategically to deliver business needs and drive process improvements
- Applies critical thinking
- Takes action and makes decisions that successfully build customer value
- Works to help others to builds strong productive relationships
- Cultivates strong business relationships with people from other areas of the organization
- Demonstrates ability to lead projects through change or transformation
- Takes risks to drive innovation
- Encourages others to achieve innovative results
- Demonstrates ability to work with teams and individuals
- Asserts personal ideas and opinions using persuasion to influence others
- Seeks opportunities to grow and develop professionally
- Uses best practices to improve business operations
- Holds self accountable for compliant and flawless execution
- Takes personal responsibility for decisions that successfully build customer value
- Effectively manages and adapts to change
- Demonstrates the courage to stand alone on ideas and opinions that differ from others
- Listens effectively and remains open to other’s ideas.
- Works effectively with people that have diverse styles, talents and ideas
- Maintains the highest standards of ethical behavior
- Treats people with dignity and respect
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards