- Work as directed by Quality Coach according to Company safety policies, cGMP and cGLP. Required to drive compliance with 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. Liaise effectively with external groups such as External testing Labs, suppliers,QS, stability hubs, etc.
- Provide oversight for the selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required.
- Ensure all external laboratory quality agreements are in place and adequately cover all applicable testing.
- Coordinates creation/ update to Quality standards for raw materials/ components and product at Carlow. Completes impact assessments for Quality standard updates/ analytical change controls and shelf-life changes related to Carlow processes initiated by off-site change owners.
- Coordinates QC equipment projects including purchasing and ensuing validation.
- Coordinates any efficiency/ increased Lab capability projects as detailed by Quality Coach.
- Represent the QC Department on site/inter departmental projects.
- 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.
- Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc, all under aseptic/clean room conditions. Provide input, review and approval for atypical, observation, and process capability investigations. On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systems.
- Participation in Internal Investigations, supplier and vendor complaints.
- QC representative for new product introduction. Attendance at associated local and global meetings.
- Coordination, ownership and author as required for Annual Product Review.
- Quality Risk Management Facilitator for QC
- Subject matter expert for Cleaning Validation/Verification
Qualifications, Skills & Experience Required:
- 3 years' experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
- Previous Analytical Experience
- Experience in Material/Laboratory Qualification
- 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
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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