Hiring Now: Qualified Person/Responsible Person Near You – Apply Today!
Your Next Qualified Person/Responsible Person Job Starts Here – Apply Now!
Qualified Person/Responsible Person
Job Posted: 19 minutes ago
Salary: £ Competitive
Job Type: Contract
Location: Dublin, Dublin City
Expire in: a month
Job Description
Qualified Person/Responsible Person
An opportunity for a QP has opened up within a Dublin based state of the art Biotech facility.
Duties/Responsibilities
• Qualified Person certification and batch release of clinical supplies
• Acts as a Responsible Person on a WDA for Pre-Approval Access
• Support for Health Authority GMP/GDP inspections and audits across the supply chain
• Advise stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
• Incorporate global regulatory trends and changes into Supply Chain Quality
• Site master file maintenance
• Manufacturers Authorisation update and maintenance
• Ensure rapid communication of quality issues or significant deviations, to business partners and senior management
• Review and approve procedural documents
• Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
• May influence the external environment through interactions with regulators, trade associations, or professional societies
Skills/Qualifications
• A degree in science, engineering or related discipline is essential along with 10 years’ experience in a role within the biopharmaceutical/pharmaceutical industry
• Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
• Previous experience as a Responsible Person on a WDA is preferred
• Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
• Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results—delivering on business and program goals
• Proven leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/ geographic/ cultural/partner boundaries
For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)Before You Apply
Do not include the following in your job application, CV, or cover letter:
- Bank details.
- National Insurance number.
- Date of birth.
You should not be asked for payment or irrelevant information. If you have concerns about a job advert or employer, seek guidance on how to proceed.
Looking for your next career move? Join a top company hiring Qualified Person/Responsible Person job near me in Dublin, Dublin City! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!
© Vita CV: Registered in England and Wales (16187919).