22464 – Quality Auditor – Tipperary Contractor

Quality Auditor

Purpose

The Quality Specialist – Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team.

Responsibilities

Sub System Ownership:

• Complete sub system ownership responsibilities as per the site System Ownership list.

Quality SME for Process, Cleaning, Water, Equipment

To provide leadership, through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.

• Includes 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. Ensures that validation status is maintained 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 the project teams.
• Develops Validation Summary Reports and assist in developing overall Quality plans for major projects.
• Works with other areas in MMD and industry to predict future trends in validation and to determine best practice.
• 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 the stages of the change control process ensuring compliance with MMD and site policies, procedures and guidelines. Principle 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 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.

Requirements

• Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field
• Validation principles and guidelines
• Understands key business drivers and uses this knowledge to make decisions and prioritise
• System Development Life Cycle
• 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