Manufacturing Compliance Specialist (Temporary) - Ireland
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Support the internal Compliance Programme within the manufacturing department.
- Self-Inspection Programme
- Management of GMP Records
- Tracking and Reporting Systems
- Escalation process
- Full understanding of basic cGMP expectations; set a good example in observance of cGMP policies.
- Lead and Participate in Self-inspections and Compliance walk-throughs of manufacturing.
- Report on the timeliness of compliance to set timelines on Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
- Managing Change Requests (CRs)
- Work with Manufacturing staff and QA Change Control to contribute to comprehensive implementation plans for CRs
- Product Change-Over
- Acquire fundamental knowledge of technical aspects of Media/Buffer Prep, Cell Culture and Purification operations
- Comply with cGMP Documentation & Operations
- Compliance with safety guidelines
The Manufacturing Compliance Specialist works within manufacturing to ensure that the manufacturing department has a robust compliance programme with a well-defined tracking and reporting process to ensure GMP compliance and audit readiness.
• BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 4+ years related to pharmaceutical manufacturing
- 5+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
- Experience leading and implementing projects
- Demonstrated ability to influence peers and teams with no direct reporting lines.
- Ability to speak, present data, and defend approaches in front of a variety of audiences.
- Organizational skills to contribute to department and cross-functional projects
- Familiarity with FDA & European GMP’s and regulatory requirements, guidelines, and recommendations.
- Strong proficiency with Trackwise
- Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
- Experience and proficiency with other applications.
- This function will perform majority of work in an office setting, reviewing documents, participating in meetings, authoring documents.
- This function may perform up to 60% of its functions at a computer terminal, the remaining 40% will be providing support on the floor.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; high pressure and temperature utility systems, risk of electrical shock and vibration.
- The noise level in the work environment is usually moderate.
- The employee may frequently be required to sit and talk or hear.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
- The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- This position requires ability to utilize a computer to perform tasks, including report generation.
- Ability to perform gown activities and enter the manufacturing plant is required.
- Other projects may include working with Benchtop analytical instruments, filter integrity testers, process tanks, Autoclaves, Labwashers, Bioreactor systems, Chromatography columns and controlling skids.
- No personnel directly report to the MFG Compliance Specialist.
- Position will provide coaching and influencing of other Mfg staff.
- Demonstrated proficiency and experience in project work within cGMP expectations for the manufacture of drugs at our company.
- Successfully achieving project goals and meeting company deadlines in timely and cost-effective manner.
- Demonstrated experience and knowledge of multi-departmental functions and issues (understanding the organization).