Senior Quality Assurance Manager
The Role
This is an exciting opportunity to work in a fast-paced environment with a small, collaborative and dynamic team of innovators and experienced leaders. The company operates a new manufacturing site in Athlone focused on innovative, new products servicing a growing global market.
The Senior Quality Assurance Manager will play a critical role in developing, maintaining and enhancing the quality standards of cGMP API manufacturing processes. The successful candidate will be responsible for developing and implementing quality assurance policies, procedures, and systems in compliance with industry regulations, Good Manufacturing Practices (GMP), and other applicable standards.
The Senior Quality Assurance Manager will report directly to the Head of Quality
Responsibilities
Work with senior management and the operations department to design and plan quality activities across the entire organisation.
Work with the quality team and management to develop, implement, and maintain the Quality Management System (QMS) in accordance with industry standards and regulatory requirements.
Oversee as a senior professional, the change control, deviation, and corrective and preventive action (CAPA) processes, ensuring proper documentation, investigation, and resolution.
Review and approve validation and qualification documents, including cleaning, process, and analytical validation, as well as equipment and facility qualifications.
Perform routine audits of manufacturing processes, facilities, and quality systems to ensure compliance with GMP and other relevant standards.
Collaborate with cross-functional teams to identify and resolve quality-related issues and drive continuous improvement initiatives.
Train and mentor junior quality assurance team, quality control team and manufacturing team members on quality standards, procedures, and best practices.
Review and approve API batch records, laboratory data, and other documentation to ensure that finished products meet the required specifications and quality standards.
Stay up-to-date with industry trends, regulatory changes, and best practices to ensure ongoing compliance and continuous improvement.
Lead the wider team throughout regulatory and customer audits / inspections.
Complete vendor and supplier qualification audits / assessments.
Carry out supplier audits in 3rd country sites.
Qualifications/ Skills
Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field; a Master's degree is preferred
A minimum of 5 years of experience in quality assurance within the pharmaceutical or API manufacturing industry, with a proven track record of success.
In-depth knowledge of GMP, ICH guidelines, and other relevant regulations and quality standards applicable to API manufacturing.
Strong analytical, problem-solving, and decision-making skills.
Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
Extremely Detail-oriented, with strong organisational and time management skills.
Ability to think creatively and laterally when problem solving and designing systems
Proficient in the use of Microsoft Office applications and relevant quality management software.
To Apply:
If you are a highly motivated and experienced Quality Assurance Professional ready to take a leadership position and contribute to the success of a growing API manufacturing company, we want to hear from you. Please submit your CV and a cover letter highlighting your qualifications and relevant experience to leah@mercuryrising.ie . Mercury Rising Limited (Trading as Dunbar Pharmaceuticals) is an equal opportunity employer and encourages applications from all qualified candidates.
Job Type : Full-time, Permanent
Salary: €48,163.85-€62,673.99 per year
Benefits:
Additional leave
Company events
Flexitime
On-site parking
Sick pay
Wellness program
Health Coverage
Schedule:
Flexitime
Monday to Friday
Supplemental pay types:
Performance bonus
Ability to commute/relocate:
County Westmeath: reliably commute or plan to relocate before starting work (required)
Work authorisation:
Ireland (required)
Work Location: In person
Competitive Salary & Benefits:
Interested candidates should submit an updated CV and cover letter to: