- Provide Quality input and guidance to ensure Lot Release (Final Packed Finished Product) of high-quality products in compliance with current Good Manufacturing Practices (GMPs).
- Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
- Support for the Secondary Packaging Operations team including performance of AQL inspections during routine operations.
- Provide Quality direction and oversight of the development and continuous improvement of new and existing processes / systems to meet customer needs.
- Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
- Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
- Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements. Minimising impact to Lot Release operations on site.
- Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
- Review and release inputs for use in manufacturing as required.
- Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies.
- Assignments may range from routine to more complex/non-routine projects/assignments, where analysis of situation or data requires a review of identifiable factors within the Lot Release operations area.
- Coordinates, plans, implements projects within specified objectives
- Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
- Reviews executed packaging batch records and associated documentation.
- Participates in customer complaint investigations if required.
- Provides training and advice to staff in order for them to perform their desired functions.
- Participation in and leading internal inspections in the Lot Release area of operations.
- Prepare reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS REQUIRED:
- Degree or 3rd level qualification (Science, Quality).
- Demonstrated experience in Lot Release and Secondary Packaging as the Quality contact for the area.
- Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
- Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
- Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels.
- Strong organizational skills, including ability to follow assignments through to completion.
- Proficiency in PC skills such as Excel, Word, PowerPoint.
- Proven decision-making capability with full accountability and responsibility.
- Demonstrated coaching skills.
- Excellent written and verbal communication skills.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations. DESIRED:
- Lot Release experience in the area of Drug Substance, Secondary and Final Packed Drug Product.
- Experience in lot release of device and combination packaged products.
- Experience in execution, documentation and follow-up of in-process inspections for Secondary Packaging processes.
- Evidence of Continuous Professional Development.
- Evidence of Validation knowledge/experience.
- MES experience.
- Good knowledge of Lean / Continuous Improvement practices and root cause analysis. BEHAVIOURS:
- Always focused on the patient and customer needs.
- Resilient profile with the ability to deliver in a challenging environment.
- Ability to engage and manage multiple stakeholders to achieve the objective.
- Curious with learning agility.
- Operationally excellent, with attention to detail.
- Organised with systematic approach to prioritisation.
- Process orientated to achieve the business objective
-
Sales & Services Associate (v)
1 week ago
Corporate Cork, Ireland Full timeType de Poste · Non-Management · Servir la clientèle internationale dès le début de leur voyage. Créer une expérience exceptionnelle et fournir un service qui fera de la clientèle des passionnés de la marque en répondant aux questions au sujet de l'établissement, des services et ...
-
Associate/Sr. Associate
4 hours ago
Eli Lilly and Company Cork, IrelandAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...
-
Associate/Senior Associate
1 week ago
Eli Lilly and Company Cork, IrelandAssociate/Senior Associate - Clinical Trial Start Up - Turkish page is loaded · Associate/Senior Associate - Clinical Trial Start Up - Turkish · Apply locations Ireland, Cork time type Full time posted on Posted 14 Days Ago job requisition id R-61995 At Lilly, we unite caring ...
-
Associate/Sr Associate
1 week ago
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 e ...
-
Associate/Sr Associate
1 week ago
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around ...
-
Associate/Senior Associate
1 week ago
Eli Lilly and Company Cork, IrelandAssociate/Senior Associate - Customer Excellence & Medical Solution (Italian & Spanish) page is loaded · Associate/Senior Associate - Customer Excellence & Medical Solution (Italian & Spanish) · Apply locations Ireland, Cork time type Full time posted on Posted 2 Days Ago job re ...
-
Associate/Senior Associate
1 week ago
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Servic ...
-
Associate/Sr Associate
1 week ago
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service ...
-
Associate/Sr. Associate
1 week ago
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 e ...
-
Associate/Snr Associate People
1 week ago
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees ...
-
Associate/Senior Associate/Manager
1 week ago
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · The purpose of the Customer Excellence & Medical Solution role is to: · • Provide a timely, professional and quality response to medical/pharmaceutical inquiries from customer (e.g. hea ...
-
Sr. Associate
4 hours ago
Eli Lilly and Company Cork, IrelandSr. Associate / Manager - Clinical Laboratory Sciences Imaging page is loaded · Sr. Associate / Manager - Clinical Laboratory Sciences Imaging · Apply locations Ireland, Cork time type Full time posted on Posted Today job requisition id R-62904 At Lilly, we unite caring with d ...
-
Associate Director
4 hours ago
Eli Lilly and Company Munster, IrelandAssociate Director - IT Manufacturing page is loaded · Associate Director - IT Manufacturing · Apply locations Ireland, Limerick time type Full time posted on Posted 2 Days Ago job requisition id R-64229 At Lilly, we unite caring with discovery to make life better for people a ...
-
QA Associate
4 hours ago
BIOMARIN Cork, IrelandWho We Are · BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutti ...
-
Retail Associate
1 week ago
HomeSense Cork, Ireland Part timeJOB DESCRIPTION Homesense is all about helping people to let their personality shine at home. We do that by bringing unique, high-quality pieces to stores throughout the country. Like our stores, our work environment is ever-evolving – and always inspiring. Because every day is ...
-
Retail Associate
1 week ago
TK Maxx Cork, Ireland Part timeJOB DESCRIPTION From designers straight off the runway to statement jewellery, we have an ever-changing product range that means the whole store experience is less about shopping, and more about the thrill of the find. It's about the exciting surprises that make the everyday a l ...
-
Tax Associate
4 hours ago
BARDEN Cork, IrelandA fantastic opportunity for a tax accountant has arisen within the tax team of a global medical technology group in Cork. Recognised as one of the best places to work due to a great culture and excellent career development opportunities. · About the position · The Tax Accountan ...
-
Lilly Cork, Ireland Full timeWe're looking for people who are determined to make life better for people around the world. · At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees ...
-
Retail Associate
1 week ago
TK Maxx Cork, Ireland Part timeJOB DESCRIPTION From designers straight off the runway to statement jewellery, we have an ever-changing product range that means the whole store experience is less about shopping, and more about the thrill of the find. It's about the exciting surprises that make the everyday a l ...
-
Associate Specialist
1 week ago
PSC Biotech Ltd Cork, IrelandJob Description · About PSC Biotech · Who we are? · PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countri ...
QA Associate - Cork, Ireland - BioMarin
Description
Who We Are
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
