Spclst, Quality Control

Job Description

A fantastic opportunity has arisen for a Spclst Quality Control.

The Specialist Quality Control is responsible for supporting Quality Control operations and quality systems to ensure compliance with company Global Quality standards regulatory requirements and current Good Manufacturing Practices (cGMP). The role provides technical expertise in QC documentation investigations and continuous improvement to support robust product quality and reliable supply.

There may be a shift element to this role so requires candidates to be flexible.

Bring energy knowledge innovation to carry out the following:

• Execute and support QC activities in alignment with company Global Policies Procedures and the Global Quality Management System.
• Ensure compliance with applicable regulatory requirements and cGMP expectations across all assigned activities.
• Demonstrate a strong culture of quality data integrity and inspection readiness.

• Author review approve and provide technical oversight for QC GMP documentation including but not limited to:
  • Laboratory Investigations
  • Quality Notifications
  • CAPAs and Effectiveness Checks
  • SOPs Standard Work Instructions (SWIs) and training documentation
  • Change Controls
  • Annual Product Reviews (APR)
  • Trend Reports
  • Out of Process Control Limit (OOPCL) events
• Act as a subject matter expert for QC documentation systems ensuring effective document lifecycle management workflow efficiency and timely approvals.
• Facilitate and mentor others in the preparation of compliant highquality documentation.
• Support QC laboratory operations through generation review and management of GMP documentation associated with routine operations and atypical events.
• Support batch disposition and release activities through timely completion of investigations Quality Notifications OOPCLs and summary reports.
• Support new product introductions (NPI) technology transfers and lifecycle activities from a QC compliance and documentation perspective.

• Lead and support deviation and investigation activities using structured root cause analysis tools (e.g. FMEA Fishbone 5Whys).
• Initiate and manage CAPAs and Quality Notifications to resolution ensuring sustainable corrective and preventive actions.
• Drive continuous improvement by identifying trends system gaps and opportunities to strengthen QC processes.

• Perform and/or support compendial assessments and analytical method validation activities as required.
• Maintain current knowledge of Irish European and international regulatory expectations relevant to Quality Control operations.

What skills you will need:

In order to excel in this role you will more than likely have:

• Degree in Science or similar
• Proven experience in cGMP Quality Control and quality systems within a regulated pharmaceutical or biopharmaceutical environment.
• Strong technical writing capability including reports standards and policies.
• Demonstrated analytical thinking and structured problemsolving skills.
• Proficiency with Microsoft Office and qualityrelated electronic systems.
• Strong attention to detail and commitment to quality and compliance.
• Effective prioritisation time management and ability to manage multiple activities concurrently.
• Clear communicator with the ability to influence collaborate and operate effectively in crossfunctional teams.
• Flexible resilient and resultsdriven approach aligned with company values.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines biologics and small molecule drug its initial launch the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

As an equal opportunity employer we are proud to be a company that embraces the value of bringing diverse talented and committed people together. Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

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