PE Global are currently recruiting for a Quality Specialist Quality Systems for our client site in Tipperary: 11 month initial contract
Role Description
The Quality Specialist Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product facilities.
Key Responsibilities
1. Ensure timely and effective completion of the Quality Systems core functions in accordance with schedules and policies, procedures, and guidelines.
2. Participate as a member of the Quality Systems Team.
Sub System Ownership
The incumbent ensures timely and effective completion of the sub system ownership responsibilities as per the site System Ownership list.
Quality SME for Process, Cleaning, Water, Equipment
Provide leadership through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
* Participating in and supporting the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group), and Equipment Qualification Validation Committee (EQVC).
* Approval of all validation documentation and ensuring compliance to MMD policies, procedures, and guidelines.
* Maintaining validation status following changes/modifications.
SAP Quality Process Steward Quality SME for Change Control
Principle 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.
Laboratory QA Oversight
Support and approve 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 incl 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 self-directed team in carrying out day-to-day functions and assigning priorities.
* The incumbent monitors appropriate performance metrics to ensure that the Co E 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 and network outside the plant.
* The incumbent promotes GMP awareness at the Ballydine site.
Experience, Knowledge & 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
Minimum of Degree or post-graduate qualification in Science, Pharmacy, or Engineering field