Pharmaceutical Quality Assurance Professional

24 hours ago

Dublin, Dublin City, Ireland beBeeQuality Part time €85,000 - €113,000

Job Opportunity: Pharmaceutical Quality Assurance Specialist

Overview of the Role

The organization seeks a meticulous and experienced Pharmaceutical Quality Assurance Specialist to oversee business activities related to contract manufacturers, suppliers, and technical due diligence.

The role involves the execution of legal duties as defined under Directives 2001/83/EC and 2001/20/EC, in compliance with EudraLex Vol. 4 Annex 16 and Annex 13, the Orange Guide, and other applicable laws, guidelines, or regulations.

  • To ensure that manufacturing activities at assigned Contract Manufacturing Organizations (CMOs) are appropriately managed in accordance with EU Good Manufacturing Practices (GMP).
  • To guarantee that manufacturing activities relating to Clinical Trial Supplies (CTS) for Investigational Medicinal Products (IMPs) manufactured and packed at overseas partner facilities are conducted in accordance with equivalent standards to those required by EU GMP.
  • To ensure that operations do not compromise the quality of medicines.
  • To maintain adequate records regarding the legal duties of the Qualified Person.
  • To participate in the audit of the organization's quality system and carry out independent audits of marketing authorization holders necessary.
  • To ensure that appropriate standards of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) are maintained.
  • To exercise due diligence in the discharge of his/her duties and report to senior management and the relevant authorities any suspicious events of which he/she becomes aware.

This role requires the ability to work independently and collaboratively within a team environment to achieve organizational objectives. The successful candidate will possess excellent communication and interpersonal skills, with the ability to build effective relationships with colleagues, partners, and stakeholders.

Required Skills and Qualifications
  • Demonstrated experience in pharmaceutical quality assurance, with a strong understanding of EU GMP regulations and guidelines.
  • Proven track record of ensuring compliance with regulatory requirements and maintaining high-quality standards.
  • Excellent analytical and problem-solving skills, with the ability to identify and address potential issues.
  • Strong communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.
  • Ability to work independently and collaboratively within a team environment.
Benefits

The organization offers a competitive compensation package, including benefits and opportunities for professional growth and development.

Other Requirements

The successful candidate will be expected to undergo regular training and professional development to maintain their knowledge and skills in line with industry developments.

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