Based in Munster, our client operates in the life sciences sector serving both commercial and development level requirements. With ambitious targets and planned introduction of additional finished products they are now seeking a Senior QA Manager (QP).
This role has primary responsibility for ensuring that the quality, safety and traceability of medicinal products are maintained within the supply chain of the products for which the client holds marketing authorisations.
- Ensure that the quality pharmaceutical products are manufactured by approved manufacturers and supplied as per approvals.
- Support product supply chain beyond geographical, regional and cultural differences among clients, manufacturers and service providers. Proactively drive and react to system trending (e.g. product reviews, deviations and complaints) to ensure ongoing quality performance and avoid short or delayed supplies.
- Establish and maintain effective communication with contract manufacturer and other clients to ensure that the management of complaints and queries takes place to match regulatory expectations.
- Maintain thorough understanding of international regulatory requirements, cGMP, ISO, corporate and client requirements pertinent to each product, market and manufacturing site.
- Ensure that batch records and validations of each supplied product-batch are reviewed for completeness, correctness and compliance.
- Annual product reviews of batches of the supplied products by manufacturers are reviewed and assessed for consistency of product quality and trends.
- Ensure that quality metrics of manufactured products vis-à-vis manufacturing sites are reviewed for untoward trend, and checks and controls, if any.
- Undertake risk assessments and mitigation, where required to ensure smooth and consistent supply chain without compromising product quality.
- Prepare, approve and maintain various cGMP documentation and technical agreements.
- Embrace “Operational Excellence” approaches to drive and deliver improvements in the delivery of services and supply chain.
- Support manufacturers with scientific and technical guidance in liaison with R&D to maintain and improve product quality within the scope of regulatory framework.
- Perform cGMP audit of contract manufacturing sites, laboratories and other suppliers and service providers.
Qualifications & Experience:
- Degree in Chemistry or Pharmacy.
- Extensive Quality Control and Assurance experiences in non-sterile and sterile formulations i.e. tablet, capsules and injectables.
- Eligibility and experience to act as European QP.
- Knowledge of EU/US quality related pharmaceutical regulations.
- Experience of conducting quality-based investigations and root cause analysis.
- Works with cross functional teams including SME’s to ensure that appropriate corrective and preventative measures are assigned.
For further information on this role, please contact Conor Harty at Harty Search & Selection;