Job Reference: JO-1912-64900_1575995363
The successful candidate will be involved in:
- Responsibility for the day to day management of the Quality Assurance (QA) function at the
- Dublin site.
- Responsible for the QA release of intermediate product batches within the site
- Support the QP for the release of finished product batches or intermediate product which is shipped off-site
- Monitoring of compliance with the requirements of current Good Manufacturing Practice
- Ensuring that the manufacturing authorisation and Site Master File are maintained as current and that the Pharmaceutical Quality System (PQS) reflects current GMP requirements.
- Provide QA expertise in support to Production and QC departments
- Responsibility for the management of the following systems:
- Documentation Management system, Internal Audit System, GMP Training System, Customer Non Medicinal Complaint System, Vendor Non-Compliance System, Deviations and Investigations system, CAPA system, The Validation system, The Supplier Qualification System, The Record Retention system, the Service Provider System (including technical agreements and external audits) and the Risk Management process.
- Responsibility to management for the scheduling of internal and external audits and the execution of audits as required.
- Responsibility to manage preparations for regulatory inspections
- Responsibility to represent the QA department during regulatory inspections
- Responsibility to represent the QA department during customer audits (e.g., due diligence)
- Responsibility for QA approval of documentation including: written procedures, executed batch records, QC results, validation reports/protocols, risk assessments and supplier evaluations.
- Responsibility for the approval (QA approval) and monitoring of contract manufacturers/contract analytical laboratories and providers of other GMP related outsourced activities
- Participation in management review of process performance and product quality as required
- Responsible for the management review of the PQS Review System to a) generate metrics with respect to PQS performance and GMP compliance at this site and b) drive quality and quality improvements and quality system improvements
- Initiate, author, and assist with documentation requirements (SOPs, reports etc.)
- Author, track, and/or ensure timely closure of commitments that QA are responsible for (e.g., regulatory inspections, deviations, complaints and audits).
Third Party Management
- QA lead for third party activities, overseeing the QA/QP release of all third-party products,
- regulatory compliance aspects and providing QA guidance to third-party sites.
- Assessment and approval of changes from third party manufacturers, ensuring there is no
- regulatory impact to the company's dossier.
- QA review and approval of analytical method transfers for third party products
- QA review and approval of master and executed batch records from third parties.
- Degree in chemistry, biology, pharmacy or a related discipline.
- Minimum of 7 years' experience in Pharmaceutical Industry
- Minimum of 3 years' experience in a QA Manager role or Senior Quality Specialist role
- (involving systems and personnel management)
- Experience managing third party CMOs
- Solid oral dose experience
- Strong working knowledge of the following quality systems: risk assessment/management,
- deviations/investigations, internal auditing, change control, CAPA and validation.
- Experience of leading QA function at regulatory inspections (HPRA, MHRA or FDA).
- Strong working knowledge of EU GMP Guidelines and ICH Guidelines
- Excellent computer skills (MS word, excel, power point)
- Ability to lead/provide input into technical investigations.
- Good communication skills
- Good problem solving skills
- Take ownership and accountability for activities
- Ability to lead and support several concurrent projects/products and develop strong relationship within cross-functional teams.
- An ability to manage the workload of a busy department.
- An ability to respond to issues and opportunities in a timely manner
- An ability to work independently and as part of a team
- Must have an ability to prioritise decisions and activities to ensure efficient use of resources
- and address critical issues impacting the QA department and the business.
- Relevant post graduate qualification (e.g., MSc / Postgraduate Diploma in Pharmaceutical
- Manufacturing Technology or other related QA qualification)
- Experience of managing a team
- Experience of introducing an electronic documentation management system
- Project management experience
- Equipment validation experience
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists