Quality Specialist Quality Systems
We are currently recruiting for a 11 month initial contract role at our client site in Tipperary.
Role Description
The Quality Specialist Quality Systems supports the Quality Systems activities in both Drug Substance and Drug Product facilities, participating as a member of the Quality Systems Team.
Key Responsibilities
* Ensure timely and effective completion of Quality Systems core functions in accordance with schedules and policies, procedures and guidelines.
* Complete sub system ownership responsibilities as per the site System Ownership list.
* Provide leadership on validation standards required for a Drug Substance and Drug Product pharmaceutical facility, including participation in PVC, WVC, CVG, and EQVC committees.
* Approve all validation documentation and ensure compliance to MMD policies, procedures and guidelines.
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 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 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.
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.
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.