Biotech Production Compliance Coordinator
A Biotech Production Compliance Coordinator is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.
This role will be responsible for performing all compliance related administrative tasks necessary for supporting commercial manufacturing operations. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.
Responsibilities:
- Performs administrative tasks in all areas of production as needed in accordance with cGMP standards and in compliance with written procedures
- As part of investigations review completed batch records and logbooks to ensure compliance with written procedure
- Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
- Monitors production processes to obtain necessary data in support of investigations and track effectiveness of changes
- Participates in cross-functional study teams to support and/or author investigations
- Gathers, trends, and analyse process related data to drive consistency and timeliness
- Document all training and maintain records for future reference
- Assists with training of new employees
- Ensures all tasks are performed in a manner consistent with safety standards
Education/Experience:
- BS/BA in Life Sciences or a related field 0-2 years of relevant work experience
- Relevant experience may be substituted in lieu of educational requirement
Skills/Competencies:
- Excellent time management, organizational, written and verbal communication skills
- Well-developed report and document writing skills
- Excellent interpersonal and communication skills; able to make complex data simple, able
- to communicate effectively with youth, work colleagues and high-level audiences
- Sound understanding of the programme management cycle and support activities
- Strong computer skills including Word, Excel, email, internet, PowerPoint
- A strong personal commitment to company values and development of junior staff
For more information on this and similar positions please contact Jack on 01 6455262 or email jack.conway-kenny at experis.ie