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Senior Compliance Specialist Job

Date: Nov 17, 2017

Location: Cork, IE

Company: MSD

Requisition ID: MAN004579

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Applications are invited for the position of Senior Compliance Specialist. The role will offer the successful candidate a unique opportunity to work as part of the Vaccine IPT team at MSD, Brinny.

The Senior Compliance Specilaist will work with the Integrated Process Team (IPT) compliance group to maintaining all aspects of compliance within the Vacciine IPT team. This includes GMP& EHScompliance. The leadership style is one of collaboration, coaching . This will require a substantial amount of his/her time within the various areas, engaging and communicating with all team members.
Activities Within Role: The Senior Compliance Specialist helps to moulds the culture to one that supports a High Performance Organisation.
  • Supports the Vaccine IPT compliance plan and quality metrics generation
  • Complete review and approval of IPT documentation 
  • Leads walk down and support audits
  • Participate in the preparation for and hosting of regulatory and customer audits
  • GMP training delivery to IPT personnel
  • Investigation of Minor Deviations
  • Investigation of EHS Incidents
  • Provide Compliance guidance to Operating procedure 
  • Review Deviation trends and identify effectiuve CAPA’s where necessary
  • Member of the site PIR team works with the Vaccine IPT to ensure that the department is Permanently Inspection Ready. 
  • Proactive monitoring of CAPAs to ensure holistic trends are proactively resolved 
  • Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA 
  • Participates in Quality Risk Management and is an IPT QRM facilitator and QRM Lead. 
Qualifications

Qualifications
  • 7 years’ experience in pharmaceutical industry. 
  • >5 years’ experience in operation /Quality role.
  • Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical. 
  • Degree in (Science/Engineering) 
Core Competencies
Knowledge:
  • MMD and site quality policies, procedures and guidelines 
  • Relevant GMP standards
  • The Quality System
  • Site procedures and policies
  • Understands key business drivers and uses this knowledge to make decisions and prioritise
Skills:
Must possess a high standard of knowledge and skills in the following areas:
  • Communication skills both written and oral including persuading others
  • Technical report writing
  • Time management
  • Problem solving skills applied to issue identification and resolution
  • Continuous improvement skills:
  • Interpersonal Team membership and leading Skills e.g.: Listening, integrating diverse
  • perspectives, adds value to the achievement of team goals.
  • Responds to non-standard requests
  • Supports cross functional investigations
  • Timely decision making.
  • Demonstrated initiative and pays attention to detail 
  • Good presentation skills. Advanced PC skills such as Excel, Word, PowerPoint. 
  • Demonbstrate the ability to coach and influence others within the Vaccine IPT
  • Organisation Skills: Ability to manage multiple priorities and to know when to escalate issues for resolution
  • Proven abiloity to work as part of a highly motivated team member
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Manuf./Operations Generic
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Employee Status: Regular
Travel:
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Company Trade Name: MSD


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