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Documentation Specialist Job

Date: Nov 18, 2017

Location: Cork, IE

Company: MSD

Requisition ID: MAN004555

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.


 


This role will be responsible for supporting the Vaccine Compliance & Documentation Group in the management of the Integrated Process Team (IPT) GMP documentation, and in supporting the Compliance Documentation functions in various administrative duties. Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers .

This requires the delivery of compliance excellence to deliver all components Good Documentation Practices, supported by a flexible, collaborative, multi-skilled teamwork environment.

Key Responsibilities:

The Documentation Specialist is accountable for the smooth execution of all appropriate documentation within the Vaccine IPT.

He/She will contribute to the High Performance culture within the Vaccine IPT by providing a flexible, accurate service to enable the IPT to achieve MMD four key priorities.

The Documentation Specialist is an active member of the cross functional IPT Team, providing support, guidance and expertise to ensure the success of the Vaccine IPT.

The Documentation Specialist will participate and comply with the MSD Quality Management System (QMS) requirements, including ownership, as relevant to this role:

Primary activities/responsibilities:



  • Updating of procedural documents;

  • Preparation of change control documentation;

  • Processing of documentation through the Change Control System;

  • Review of batch records and recording of incidences of corrections made to batch records;

  • Generation and control of protocols.

  • Quality & Safety Compliance monitoring including reporting, metrics, etc

  • Investigation Support

  • Issuance of documents to the Operations Department

  • Any other duties assigned by your lead.
Qualifications

We require a candidate with :



  • 4+ years experience of working in a similar documentation related role in the Pharmaceutical Industry

  • Knowledge of EU/US quality related pharmaceutical regulations

  • Degree in Science or related discipline preferable

Key Experience:



  • Computer literacy is essential.

  • Strong communication skills.

  • High level of technical aptitude

  • Demonstrated initiative and pays attention to detail

  • Good presentation skills.

  • Motivated.

  • Highly disciplined and organized

  • Ability to organise & coach less experienced colleagues in the group

  • Ability to work as part of a team

 


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
Other Locations:
Employee Status: Regular
Travel:
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Shift (if applicable):
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Company Trade Name: MSD


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