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Senior Documentation Specialist Job

Date: Nov 17, 2017

Location: Cork, IE

Company: MSD

Requisition ID: MAN004583

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 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 Senior Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within the Vaccine IPT . The Senior Documentation Specialist will be the Vaccine IPT Documentation and Change Control SME. They will provide guidance to Documentation Specialists withing he Vaccine IPT and coordination the work of other Documentation Specialists.
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 Senior 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 MMD Quality Management System (QMS) requirements, including ownership, as relevant to you.

Primary activities/responsibilities:
  • Coordinate the activities within the Vaccine IPT Documentation Control
  • Organisation Skills: Ability to manage multiple priorities and to know when to escalate issues for resolution
  • IPT Documentation SME. Ability to coach and train others within the department
  • Ensure strong project focus and ability to work closely with the Project Manager(s) in coordinating documentation deliverables and meeting project scope and will own assigned tasks for the entire project, or portions of project. 
  • Ability to lead projects within the Documentation Control area.
  • Ensure compliance with cGMP and other business compliance regulations.
  • Continually evaluates Documentation progress and effectiveness and implements continuous improvements where necesary.
  • Participate in risk assessments, inspections, audits, incident investigations and implement and follow-up related CAPA’s.
  • Preparation of change control documentation;
  • Processing of documentation through the Change Control System;
  • Updating of procedural documents;
  • Complete review of IPT documentation 
  • Generation and control of protocols.
  • Generation of Strategy documents
  • Quality & Safety Compliance monitoring including reporting, metrics, etc
  • Investigation Support
  • Issuance of documents to the Operations Department
  • Ensure compliance with cGMP and other business compliance regulations.
  • Continually evaluates Documentation progress and effectiveness and implements continuous improvements where necesary.
  • Participate in risk assessments, inspections, audits, incident investigations and implement and follow-up related CAPA’s.
  • Participate and comply with the MMD Quality Management System (QMS) requirements, including ownership, as relevant to you.
  • Any other duties assigned by your lead. 
Qualifications

Qualifications
Education Requirements
  • Minimum of Degree in Science, 
  • Evidence of Continuous Professional Development
Experience:
  • At least 5 years experience in the Pharmaceutical industry or a similar operating environment. 
  • 5+ years experience of working in a similar documentation related role in the Pharmaceutical Industry 
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. 
  • Manufacturing, Quality, Engineering, etc.).
  • Knowledge of EU/US quality related pharmaceutical regulations 
Core Competencies
Knowledge:
  • MMD and site quality policies, procedures and guidelines 
  • Relevant GMP standards
  • The Quality System
  • Site procedures and policies
  • Site equipment, layout, documentation
  • 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:
  • Computer Applications: Word, Excel and Email Management.
  • 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. 
  • Ability to organise & coach other Documentation Specialists within the Compliance & Documentation Group 
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.

Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



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


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