This innovative pharmaceutical company is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research the world over. This organisations customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The company operates in 35 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide and is committed to accelerating customer success through innovation and leadership in Life Science and High Technology.
- Ensure compliance with all quality regulations in a manner consistent with continued plant profitability.
- Co-ordinate and prioritise all quality compliance and auditing activities on site.
- Manage department budget in line with expectations, as well as regulatory spend within AOP, pursuing cost reductions in all possible areas.
- Ensure competence and motivation of all QA/QC personnel by clearly outlining expectations, training appropriately, setting objectives, managing performance and long term development of staff.
- Participate fully as a member of the sites Leadership Team, assisting with the determination of future strategy and goals.
- Ensure that all policies and procedures comply with cGMP requirements. Maintain thorough and up-to-date knowledge of relevant regulatory requirements (FDA, cGMP, customer and other relevant regulatory bodies); ensure that all relevant requirements and updates are communicated in a timely manner to all appropriate departments onsite.
- In close co-operation with the Operations Manager, oversee resolution of any customer related quality issues; verify implementation of corrective actions to address all production issues that contribute to out-of-specification batches.
- Develop and manage the site Validation Master Plan in accordance with regulatory and corporate requirements
- Review and drive compliance of site Quality Systems to ensure they fulfil the requirements of all relevant corporate policies
- Act as primary point of contact for FDA, IMB, and other regulatory bodies, as well as for customer audits, technical visits and other quality related issues.
- Responsible for organizing and leading plant’s responses to quality audits by customers and regulatory agencies.
- Lead and train staff in robust root cause analysis investigations to compliment and aid closure of deviations and complaint resolution to prevent re-occurrence.
- Degree (Chemistry, Chemical Engineering, Pharmacy, Biological Science).
- QP or equivalent.
- Thorough understanding of quality regulatory policies, procedures, and processes.
- Strong people management skills to include people development and performance.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application