QA Specialist/Director of Quality EU

QA Specialist/Director of Quality EU
  • €100,000 per Annum
    ANNUM
  • Temporary
  • Dublin, Republic of Ireland dublin Dublin Dublin 1Dublin IRE2022
Job Ref: NM0035
Sector: Science, Pharmaceutical & Food
Date Added: 05 September 2022

IRC Recruitment is currently hiring on behalf of a client for the role of a QA Specialist/Director of Quality EU within the pharmaceutical industry.

Title: Director of Quality

Salary: €100,000.00

Location: Dublin

Bonus: 10%

Hours: 39

Work Travel: Yes, when needed for internal audits on other sites. This would only be 1-2 times a year but can vary based on business needs.

Hybrid Eligible: 1 day per week (depending on business needs)

Probation Period: 6 Months

Benefits: Pension 5% Employer, 5% Employee (after probation)

Healthcare (after probation)

Employee Assistance Programme

Life Assurance/income protection (after probation)

Education Assistance Programme

Perks Discount Card

Bike to Work/ Tax Savers

80% paid paternity/maternity leave

Purpose of the Position/ Role Summary

Provides leadership and direction to drive manufacturing operations and suppliers towards higher quality products and processes in accordance with corporate strategy, cGMP, and regulatory compliance. This includes developing strategic business plans and the tactical actions and resources necessary to execute them. The Director will be responsible for managing operational budgets including leading continuous improvement initiatives in quality. This role is responsible for the day to day management of Quality Control, Microbiology, and Quality Assurance for the site.

Key Role Specific Requirements

  • Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
  • Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes (eg Continuous Improvement) and supporting new product development.
  • Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance.
  • Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analysing variances; initiating corrective actions.
  • Monitors QA systems and advises executive team on system performance; publishes statistics regarding performance against set goals and makes recommendations.
  • Leads the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
  • Acts as the primary contact with regulatory agencies for all communication for the site.
  • Leads by example and proactively communicates and collaborates with internal staff, colleagues, the union and external stakeholders to drive results.
  • Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
  • Responsible for ensuring that all product quality complaints are being adequately investigated, trended, & reported and collaborates with department to ensure full customer satisfaction.
  • Responsible for final product release to customer.
  • Acts as a liaison with customer auditors and ensures corrective actions are completed according to customer specifications.
  • Participates as required in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Approves/rejects as required.
  • Organizes and hosts facility audits by customers, HPRA including responding to corrective actions and /or observations as required.

Competencies Required for the Role

  1. ACCOUNTABILITY/EXECUTION - A willingness to accept responsibility or to account for one's actions.

Accountability is when an individual or a department experiences consequences for their performance or actions

  1. ADAPTABILITY/CHANGE AGILITY - Is the ability to be agile and adapt to constant change; shows good resistance to pressure and stress; is resilient and open-minded. The ability to demonstrate support for innovation and for organizational changes needed to improve the organization's effectiveness, initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.
  2. AMBIGUITY- The ability to be comfortable with change and uncertainty. The ability to deal with fuzzy problems with limited data and with no clear solutions. The ability to juggle several projects or to not bring closure to one project because of business changing needs.
  3. INTEGRITY/PERSONAL CREDIBILITY - Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
  4. JUDGEMENT - is the ability to make considered decisions or come to a sensible conclusion

Other Requirements

Essential:

  • Ten years' relevant experience in a regulated pharmaceutical industry including Quality Assurance, Quality Control, with 5 years in a leadership role
  • Practical experience acting as Qualified Person releasing product into the Irish and European Markets
  • BSc degree in science or related field
  • Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing, and packaging processes
  • Must possess apparent leadership qualities to be able to interface and communicate with all levels internally and externally comfortably and successfully.

Desirable:

  • MS degree or MBA as asset

Guidant IRC is acting as an Employment Agency in relation to this vacancy.

Irish Recruitment https://www.irishrecruitment.ie https://www.irishrecruitment.ie/-/media/irishrecruitment/logos/irc-logo-80px-height.png
05/10/2022 09:53:50
EUR 100000 100000 Annum
Contact Consultant:
Nikola Malikova

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