Quality SpecialistCork, Ireland Job ID JR0102283 Category Quality Assurance Post Date Nov. 20, 2023
PURPOSE OF JOB
Reporting to the Quality Compliance Manager, the post holder will have the responsibility for monitoring compliance to the Quality Management System as per applicable regulations and company policies. The key function of this role is to minimize the risk to McKesson private label business by ensuring a high level of quality and regulatory compliance. Provide quality direction and oversight of the development and continuous improvement of quality systems to meet applicable regulations and evolving business needs while maintaining the eQMS in a validated state.
- Review, approve quality records (change controls, deviations, CAPAs, procedures, validation and other quality related documents. Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
- Quality oversight ensuring compliant operation and maintenance and system administrator of eQMS, liaising with application vendor in resolving issue and annual upgrades
- Coordinate internal audit program
- Support and participate in the preparation for regulatory and customer GMP inspections
- Support the co-ordination of Contract Manufacturing Organization (CMO) change notifications, assess where required and support the management of change within the QMS.
- Conduct GMP training as required, including roll out of Multi-disciplinary cross training and training on the electronic QMS
- Analyze and trend data, generate metrics and prepare reports for the Quality department and management, escalate any product, supplier or system issues found, tracking to resolution
- Drive continuous improvement of processes to ensure quality is maintained while efficiency is optimized
- Maintain a good understanding of existing and emerging pharmaceutical regulations and evaluate the impact on the private label business
- Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business
- Support cross-training opportunities and skills
- Provide day-to-day department support activities as necessary to aide completion of project deliverables
- Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required and cross training as required.
ADDITIONAL RESPONSIBILITIES AND DUTIES
(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management. When in conflict with the job description, the Staffing Request and Job Posting supersede the job description)
Educated to degree level, ideally B.Sc. in Chemistry, Bioscience, Microbiology or other scientific discipline.
Experience: 5+ years GMP experience in a progressive multinational pharmaceutical/medical device organization with 3 years minimum in a Quality Assurance role.
Knowledge and Skills:
- In-depth understanding and knowledge of cGMP standards and Quality Management and regulatory principles in a GMP environment and the ability to implement appropriately
- Experience of reviewing and approving Quality records
- Prior experience of system administration of an eQMS (MasterControl, Trackwise, ETQ) on an enterprise level is an advantage.
- Experience of GAMP5, 21CFR Part 11, CSV, Project Life Cycle and GxP Regulations is an advantage.
- Excellent organizational and time management skills with the ability to prioritise and manage projects within a team environment to ensure the critical tasks are completed on time and meet requirements.
- Excellent interpersonal skills, self-motivation and sense of urgency to make decisions based on judgement and integrity, completing assignments on time
- Proven analytical skills and ability to transfer findings into report and presentation formats
- Excellent verbal, written, and interpersonal communication skills with ability to communicate at all levels within the organization
- Ability to work effectively with others to accomplish goals in a challenging environment
Proficient in Microsoft office. Essential experience of being a system owner of GxP eQMS system.
Work Environment/Physical Demands:
Hybrid working model with the ability to work from home and in the general office environment. International travel may be required occasionally to meet business needs
At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.
As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
Our Base Pay Range for this position€48,000 - €80,000
How we work and live plays a big role in building a healthier world. View our wide range of health benefits, financial benefits, wellness programs, and flexible working schedules.
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