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