The Quality Systems Specialist supports the activities in both the Drug Substance and Drug Product facilities. This role is part 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: Provide leadership through knowledge and skill regarding validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
* Approval of all validation documentation and ensuring compliance to MMD policies, procedures and guidelines.
* Ensures that validation status is maintained following changes/modifications.
* SAP Quality Process Steward: Quality SME for Change Control.
* Principle Quality contact for all site change requests (with impact on processing).
* Laboratory QA oversight: Support and approve the systems supporting laboratory functions, instrumentation and GLIMS.
* Stability oversight: Review and approval of stability reports.
* Microbiology Point of Contact: Knowledge of microbial requirements in the pharmaceutical industry.
* Quality Agreement System Management: Manage the site inventory of Quality Agreements.
* Annual Review System Management: Manage the system ensuring that Annual Reviews are completed to meet the Annual Review schedule.
* Quality Oversight of site application User Access Reviews: Approval of all designated user access reviews.
* Supplier Change Evaluations - Quality Role: Review and approve Supplier Change Evaluation documentation.
* Returned Goods: Manage the segregation and disposition of all returned goods.
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.