What you need to know
Matrix Recruitment Group are currently recruiting for a Site Compliance and Product Release Senior Specialist / Qualified Person for our client in the Pharmaceutical industry based in Offaly.
Your new job
- Support the implementation & continuous improvement of an effective quality management system including quality oversight across the site
- Assume an active role in the creation, modification and maintenance of the Quality Management Systems supporting operational and release functions
- Review & approval of batch records and associated raw data for manufacturing operations to ensure compliance with the requirements of cGMP and batch review and batch disposition process
- Participate in and support Site License registration process and future license updates
- Review of analytical data and associated reports
- Review and approval of non-conformance events and reports including deviations, laboratory investigations & environmental excursions
- Perform batch review and approval of investigational veterinary products and commercial products
- Participate in or lead internal and external audit including 3rd party audits and supplier reviews
- Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved
- Initiate and implement change control activities in accordance with site procedures
- Assist with oversight of issue management and non-conformance events to ensure compliance and timely closure
- Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities
- Partake in or lead periodic quality review meetings to ensure compliance and continuous improvement
- Write or assist in writing, reviewing and approval of SOPs and other GMP documents
- Develop and where appropriate deliver training across the teams regarding the quality topics and metrics
What are we looking for?
- BSc, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering) and be QP qualified.
- At least 5-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment.
- Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.
- Experience of interaction with cross functional departments.
- Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management.
- Ability to support relevant sections of CTD for regulatory submission.
- Excellent interpersonal and communication skills, meticulous eye for detail.
Apply for this job now via the link below
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