The Quality Control Specialist supports quality control activities as required relating to product schedules including any project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release. Provide technical expertise, troubleshooting, training and support to laboratory technicians. Ensures Quality Control readiness to support all scheduled activities, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.
- Work as directed by Quality Coach according to Company safety policies, cGMP and cGLP. Required to drive compliance with company Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Facilitate and drive effective communication to ensure success. Facilitate / Attend tier meeting for QC function and other support functions as necessary ensuring that the relevant group representatives attend to confirm all testing and validation activities are on schedule.
- Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
- Acts as an SAP Master Data process steward to ensure all material inspection plans are created in accordance with material introduction schedules.
- QC representative for Material Review Board, Change Review Board and New Material Introduction process.
- Update of all procedures and test specifications associated with new material introduction process.
- Primary QC contact for all supply change notifications and update of all relevant procedures, test specifications and SAP as a result of same.
- Change control owner for QC activities, QC impact assessment and task completion as required
- Author for Annual Product Review
- Assessment of QC impact as a result of Pharmacopeil and Quality standard updates
- Lead thorough Investigations in the QC area, ensuring effective CAPA implementation in a timely manner and meeting site KPI’s
- Generation of and continuous monitoring of QC KPI’s. Driving improvement projects where targets are not being achieved
- Lead and participate in all improvement projects and QC Hoshins within the area.
- Coordinate retain management for QC Components and Drug Product
- Support continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues.
- 1 – 3 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Degree in Science, Engineering or similar
- Lean Six Sigma Yellow Belt or suitable alternative
- Knowledge of cGMP in Laboratory Quality Systems
- Proficiency in Microsoft Office and job-related computer applications required
- Demonstrated experience in Report, standards, policy writing
- Understanding of Lean Six Sigma Methodology preferred.
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
- Good communication, interpersonal skills and ability to work across teams.
- Demonstrated ability to drive the completion of tasks
- Proven decision-making capability with accountability and responsibility
- Demonstrated ability to solve problems
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email firstname.lastname@example.org