MSD Manufacturing Specialist Compliance Support 

Ireland 

186404983

Job Description

What you will do:

Bring your energy, knowledge, and innovation to:

• Initiates and executes Quality and compliance improvements / changes.
• Supports and Drives Operations Team on improving performance to meet both Quality & Compliance standards and all associated Key Performance Indicators.
• Supports Operations Team on quality and compliance related issues through completion of investigations and implementation of robust CAPA’s.
• Quarterly trending, CAPA strength assessment and Root Cause Analysis.

Advise

• In regard to both Quality and Compliance, advise the Operations Support Lead and team of operations specialists using specialised technical pharmaceutical knowledge regarding the effect to product quality due to changes/deviations in process

Policies and Specifications

• Evaluate on request the consequences of external guidelines, as well as initiate and develop policies and GMP procedures. For example, Change controls, Deviations and QMS sub-systems ownership.

GMP Inspections and activities

• Actively advise and support the Operations Team regarding GMP inspections; both internal and external. Track QSAT actions and findings. Act as QSAT owner

Improvements

• Initiate and formulate proposals / business cases for quality improvement projects including deliverables and planning for the development and implementation of proposed improvements.

Problem solving & Deviation Management

• First point of contact both within and external to the department for quality and compliance issues (Deviation management).
• Be responsible for quarterly trend reports.
• Monitor QN KPI’s – adherence to critical stage gates (raised on time, classified on time, and closed on time)
• Quality Council representative for Operations team

Quality Management system

• Subject matter expert and coach for Topic 3.5 Deviation Management
• Topic owner for Topic 6.5 Production and Controls

What skills you will need:

• Bachelor’s or Master’s degree in engineering, pharmacy or science related field
• Five years previous experience within Quality operations/ Compliance or Operations role within a Pharmaceutical Company.
• Excellent command of English, both written and verbal – ability to work within all levels of the organisation.
• Experience in root cause analysis tools, CAPA identification and authoring of deviations is essential.
• SAP knowledge is an advantage.
• Experience in tracking and reading out on performance metrics is an advantage.
• Ability and willingness to keep learning.
• A team player, who is able towork autonomously.
• Strongcommunication skillsand proven track record of coaching others
• Sense of initiative and overall coordination of projects and activities

please apply today.

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.