Quality Manager

Quality Manager

Main Duties and Responsibilities

·      Quality Control for HPRA Manufacturing Licence, for repack operation.

·      Overall responsibility of the quality management system based on ISO9001:2015 and ensuring that it is implemented and maintained within the company. Which covers pharmaceutical product (ambient and cold chain), food (ambient and cold chain) and household products.

·       Ensure that all members of the management team are made aware of any significant changes in regulations which may impact on the business of the company.

·       Responsible for implementing and coordinating HAACP and Food Defence programs. Also maintaining BRC issue 3, Storage and Distribution and other client food safety standards.

·       Establish and implement necessary communication strategy for the improvement and awareness of quality issues across all departments.

·      Responsibility of ensuring that all essential quality information is communicated to the relevant people on a regular basis (e.g. meetings, e-mails, notice boards).

·      Liaise and co-operate with quality management and standards bodies.

·      Responsibility of ensuring that all regulatory requirements are communicated to relevant management with respect to storage and distribution of product where appropriate.

·      Develop and maintain system for the investigation of complaints and deviations and that any corrective/preventative actions identified because of such investigations are approved and implemented in a timely manner.

·      Develop and maintain systems are in place for handling any audits/inspections and also that any commitments arising from such inspections are closed out within the agreed timeframe.

·       Develop and maintain system in place to ensure that computerised systems operate in a controlled manner.

·      Develop and maintain systems to establish standards (Standard Operating Procedures) relating to various departments.

·       Develop and maintain systems to measure performance against established standards. Monitor performance (in relevant areas) according to agreed standards and take necessary action to communicate/advise/assist according to performance levels.

·       Liaise with customers and suppliers where necessary (where impacting/affected by quality issues)

·       Issue Quality Department Monthly KPI reports

·       Validation and Qualification of temperature monitored and controlled warehouse and transport routes.

·       Review of temperature records

·       Management of the calibration schedule

·      Completion and approval of Customer and Client bona fides

·       Approval of suppliers and carriers

·      Manage all PRL HPRA licenses

·      Review of technical agreements

·      Complete operational risk assessments

·       Coordinate changed controls

·       Monthly Quality meetings with operations, and annual QMS review • Strong communication skills

·      Strong planning, organisational, teamwork and presentation skills

·      Be flexible and dynamic with and ability to meet multiple challenges in an evolving fast-paced work environment

 • Full clean drivers licence

Successful candidate will have:

• Minimum BSc in life sciences, science or supply chain

• Knowledge of ISO9001:2015, or similar Quality Management System

• Knowledge of GMP, GDP and/or Food safety guidelines

• 4 - 5 years’ experience in a Quality Management Role

• Ability to work carefully, methodically and accurately.

• Analytical and problem-solving skills.

• Time management skills and organisational skills. Ability to handle multiple tasks while remaining focused.

• Self-motivated and committed to achieving deadlines.

• Able to handle difficult situation with tact and diplomacy.

• Good interpersonal skills.

• Conscientious, motivated and willing to learn.

• Ability to work independently and in team-based environments.

For more information please contact Clodagh D’Arcy on [email protected] or 0873470221