Quality Specialist - Quality Systems
The Quality Specialist - Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product facilities in Ballydine. This role participates as a member of the Quality Systems Team.
Key Responsibilities:
* Ensure timely and effective completion of Quality Systems core functions in accordance with Ballydine schedules and MMD policies, procedures, and guidelines.
* Complete sub-system ownership responsibilities as per the site System Ownership list.
* Provide leadership through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
* Participate in and support the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group), and Equipment Qualification Validation Committee (EQVC).
* Approve all validation documentation and ensure compliance to MMD policies, procedures, and guidelines. Maintain validation status following changes/modifications.
* Support the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams.
* Develop Validation Summary Reports and assist in developing overall Quality plans for major projects.
* Work with other areas in MMD and industry to predict future trends in validation and determine best practices.
* SAP Quality Process Steward.
* Quality SME for Change Control.
* Principal Quality contact for all site change requests (with impact on processing). Provide Quality and change analyst review for all change requests through all stages of the change control process ensuring compliance with MMD and site policies, procedures, and guidelines.
* Principal Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.
* Laboratory QA oversight.
* Support and approve the systems supporting laboratory functions, instrumentation, and GLIMS. Provide Quality oversight and approval for laboratory incidents/investigations and documentation.
* Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate).
* Microbiology Point of Contact. Knowledge of microbial requirements in the pharmaceutical industry, to liaise with site Microbiologist for all microbial issues (eg, water, utilities, environment, excipient, or product and as necessary).
* Quality Agreement System Management.
* Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships. Interact and communicate with SD&PM, relevant stakeholders, and external parties to ensure appropriate Quality Agreements are current, approved, on file, and retrievable.
* Annual Review System Management.
* Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems (including automation) are completed to meet the Annual Review schedule.
* Creation, review, and approval of Site Quality documentation including;
* Site Master File, Validation Master Plan, policies, or procedures.
* Quality Oversight of site application User Access Reviews.
* Approval of all designated user access reviews, ensuring compliance with site and MMD policies and procedures.
* Quality Council.
* Manage the annual quality council schedule.
* Manage the monthly quality council agenda, minutes, and action follow-up.
* Supplier Change Evaluations - Quality Role.
* Review and approve Supplier Change Evaluation documentation.
* Complete/Approve MDS updates post SCE approval.
* Approve Supplier Transparency update change requests post SCE approval.
* Generate quality/technical agreements with suppliers as appropriate.
* Supplier and Customer complaints.
* Participate in the investigation and review of any internal/external customer complaints in accordance with agreed lead-times.
* Participate in the investigation and review of any supplier complaints in accordance with agreed lead-times.
* Filing & Licence maintenance and Regulatory Requests follow-ups.
* Review and ongoing maintenance of site licences.
* Provide site documentation to support product filings in accordance with CMC requests.
* QA Regulatory Data:
* Review and verify documentation that may be used for submission to Pharm- CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program.
* Returned Goods.
* Manage the segregation and disposition of all returned goods.
* Audit program.
* Support the internal GMP walk-down and scheduled audits program.
* Support hosting of site Regulatory Inspections.
* Special Features:
* The incumbent operates as part of a self-directed team in carrying out day-to-day functions and assigning priorities.
* The incumbent monitors appropriate performance metrics to ensure that the CoE delivers on all responsibilities in line with business needs.
* On assignment, the incumbent participates in departmental initiatives on improved compliance, and quality systems, and participates in cross-functional interdepartmental teams.
* The incumbent must be assertive with excellent communication skills, who can develop cross-functional relationships at Ballydine and network outside the plant.
* The incumbent promotes GMP awareness at the Ballydine site.
Experience, Knowledge, and Skills:
* Technical:
* MMD and site quality policies, procedures, and guidelines which relate to the Quality Assurance function and plant quality systems.
* Relevant GMP standards.
* Global Engineering Standards.
* Plant procedures and policies.
* Plant equipment and Unit Operations.
* Plant layout.
* Plant documentation.
* Laboratory testing and documentation.
* Validation principles and guidelines.
* Understands key business drivers and uses this knowledge to make decisions and prioritize.
* System Development Life Cycle.
* Business:
* The Specialist must demonstrate the MMD core values and behaviours.
* The Specialist must possess a high standard of knowledge and skills in the following areas:
* Computer Applications: Word, Excel, Access, eLogs, File and Email Management.
* Meetings Management.
* Technical report writing.
* Time management.
* Analytical Problem-solving skills applied to issue identification and resolution.
* Continuous improvement skills:
* Responds to non-standard requests.
* Supports cross-functional investigations.
* Timely decision making.
* Inclusion behaviours.
* Leadership:
* Strong Communication skills both written and oral including persuading others.
* Pro-active approach.
* Planning and scheduling.
* Brainstorming/Ideas generation - tools and techniques.
* Customer service.
* Interpersonal Skills.
* Facilitation skills.
* Interpersonal Team membership and leading Skills eg. Listening, integrating diverse perspectives, adds value to the achievement of team goals.