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Ovaj oglas je istekao 23.05.2018. i više nije aktivan.
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Trenutno aktivne oglase pogledajte na www.posao.hr.
Ovaj oglas je istekao 23.05.2018. i više nije aktivan.
Sadržaj oglasa prikazan je isključivo u informativne svrhe.
Trenutno aktivne oglase pogledajte na www.posao.hr.
SR Compliance Specialist (m/f) - Process Sciences
Oglas je istekao
Poslodavac:
Kategorija:
Mjesto rada:
Limerick, Ireland
Rok prijave:
23.05.2018.
O poslu
Opis radnog mjesta:
Requisition Number: 12155BR
Employment Type: Regular Employee
Position Summary
Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.
Summary:
Supports the Process Validation and Manufacturing Support group within the Process Sciences department by providing oversight for all aspects of cGMP compliance.
The individual will be part of a dynamic scientific and technical team in a fast-paced environment and work closely with cross functional teams.
Essential Duties and Responsibilities may include, but are not limited to, the following:
• Manage product impact assessment (PIA) request process, PIA allocation to team members and track PIAs progress.
• Monitor and Track progress of all MFG Support group owned quality records, such as deviations, Change controls and CAPAs.
• Strong communicator to represent team at cross functional quality meetings
• Be a SME for quality records and quality systems, ensuring consistency of records.
• Train and promote technical writing and quality awareness
• Maintain and communicate appropriate metrics
• Review team owned quality records for compliance and accuracy
• Represent PS at daily & weekly cross functional notice of event meetings
• Develop an effective compliance framework for the Process Sciences department through the development and implementation of appropriate compliance related policies and procedures.
• Act as a liaison between the MFG Support group and onsite quality and regulatory groups to define and address all issues of non-compliance.
• Drive proactive compliance environment in the MFG Support team through knowledge transfer and education of compliance related items.
• Coordinate/perform training for MFG Support personnel on regulatory and quality topics
Employment Type: Regular Employee
Position Summary
Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.
Summary:
Supports the Process Validation and Manufacturing Support group within the Process Sciences department by providing oversight for all aspects of cGMP compliance.
The individual will be part of a dynamic scientific and technical team in a fast-paced environment and work closely with cross functional teams.
Essential Duties and Responsibilities may include, but are not limited to, the following:
• Manage product impact assessment (PIA) request process, PIA allocation to team members and track PIAs progress.
• Monitor and Track progress of all MFG Support group owned quality records, such as deviations, Change controls and CAPAs.
• Strong communicator to represent team at cross functional quality meetings
• Be a SME for quality records and quality systems, ensuring consistency of records.
• Train and promote technical writing and quality awareness
• Maintain and communicate appropriate metrics
• Review team owned quality records for compliance and accuracy
• Represent PS at daily & weekly cross functional notice of event meetings
• Develop an effective compliance framework for the Process Sciences department through the development and implementation of appropriate compliance related policies and procedures.
• Act as a liaison between the MFG Support group and onsite quality and regulatory groups to define and address all issues of non-compliance.
• Drive proactive compliance environment in the MFG Support team through knowledge transfer and education of compliance related items.
• Coordinate/perform training for MFG Support personnel on regulatory and quality topics
Vrsta posla:
stalni radni odnos
Županija:
Država:
Ireland
O zaposleniku
Znanja i kvalifikacije:
Education and Experience:
• Highly desirable for a scientific and quality background
• Requires BSc/Masters in scientific discipline or related field with 6+ years of relevant work experience in pharmaceutical or related industry.
• Minimum of 4+ years’ experience working in a Compliance function in a cGMP environment.
• Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization.
• Strong Technical writing ability.
• Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint)
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.
Application link
• Highly desirable for a scientific and quality background
• Requires BSc/Masters in scientific discipline or related field with 6+ years of relevant work experience in pharmaceutical or related industry.
• Minimum of 4+ years’ experience working in a Compliance function in a cGMP environment.
• Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization.
• Strong Technical writing ability.
• Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint)
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.
Application link
Minimalna stručna sprema:
Viša škola
Strani jezik:
engleski
Poznavanje rada na računalu:
napredno
