The Quality Assurance Manager position is a permanent and full-time role at a leading organization.
Job Description
We are seeking a highly skilled Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring the quality of our products and services, while also contributing to the development of our Quality Management System (QMS).
Key Responsibilities
* Quality Management System Development: Develop, implement, and maintain the QMS to ensure compliance with regulatory requirements.
* GDP Compliance: Ensure adherence to GDP guidelines (2013/C 343/01) and HPRA requirements (IA-G0046) across all distribution activities.
* Training and Development: Promote a strong quality culture through continuous training, retraining, and effective communication of quality processes.
* Supplier Management: Verify that only authorized product classes are sourced from approved suppliers and supplied to approved customers in line with the company's WDA.
* Service Provider Qualification: Assist with the qualification and approval of outsourced service providers and transport routes as required.
* Documentation Control: Review, draft, and implement controlled documentation including SOPs, deviations, change controls, validations, and related records.
* Supplier Verification: Perform initial and ongoing bona fide checks on suppliers and customers as assigned.
* Risk Management: Contribute to the maintenance of a company-wide risk management culture.
* Agreement Management: Review and update Quality Technical Agreements, ensuring agreements are in place with all relevant suppliers, customers, and service providers.
* Product Returns: Manage product returns within the supply chain: secure handling, appropriate reporting to the Responsible Person (RP), and ensuring non-compliant products are not released for sale.
* Temperature-Controlled Shipments: Assess temperature-controlled shipments and provide quality decisions regarding product impact.
* Temperature-Controlled Activities: Monitor all temperature-controlled activities within the supply chain, including warehouse conditions.
* Adverse Drug Reactions: Escalate suspected adverse drug reactions (ADRs) or product quality defects to the RP for reporting to Competent Authorities and Product Authorisation holders.
* Product Recalls: Coordinate and execute product recalls in a compliant and timely manner.
* Deputy Responsible Person: Act as Deputy Responsible Person (dRP) on the company's Wholesale Authorisation, assuming RP duties during their absence with appropriate handover.
* Record Keeping: Execute delegated RP responsibilities and ensure accurate record keeping of these activities.
* Supply Chain Continuity: Safeguard continuity of supply while ensuring that commercial decisions never compromise product quality, patient safety, or compliance.
* Falsified Medicines: Escalate any suspected falsified medicines to the Competent Authorities and Product Authorisation holders without delay.
Requirements
To be considered for this role, you will need to have:
* A degree in a relevant field such as science, engineering, or business.
* Proven experience in quality assurance and control.
* Knowledge of GDP guidelines and HPRA requirements.
* Excellent communication and interpersonal skills.
* Able to work independently and as part of a team.
What We Offer
This is a fantastic opportunity to join a dynamic organization and contribute to the success of our quality assurance team. We offer a competitive salary and benefits package, including:
* A generous pension scheme.
* Opportunities for career development and progression.
* A friendly and supportive work environment.
* Access to the latest technology and equipment.
About Us
We are a leading organization dedicated to providing high-quality products and services to our customers. Our values include:
* Innovation.
* Excellence.
* Collaboration.
* Integrity.
We are committed to making a positive impact on society and the environment, and we strive to create a workplace that is inclusive, diverse, and respectful of all individuals.