QC Raw Materials Analyst

Dormont Manufacturing Co; Cork; On-site; EUR 42,000 - 60,000; Full time

Job summary

Dormont Manufacturing Co is seeking a QC Raw Materials Analyst in Ireland to ensure timely, compliant analysis of incoming raw materials supporting site operations.

You will perform sampling/analysis, update the Retain/ SAP results, and participate in investigations and trend reporting within a GMP setting.

Qualifications

• A third level Science Qualification or equivalent.
• Basic pharmaceutical experience in a GMP regulated laboratory environment.

Responsibilities

• Sampling and analysis of materials (excipients, packaging components).
• Entering results on SAP and verifying specifications.
• Maintaining and updating documentation and SOPs in line with cGMP.
• Supporting investigations (MQIs, vendor complaints, LIRs) and internal audits.
• Generating/ Reporting KPIs for the QC group and assisting in trend analysis.

Skills

Communication

Flexibility

Change management

Education

Science degree

Tools

SAP

Job description

Job Description Summary

We are seeking a motivated QC Raw Materials Analyst to join our team, where you will play a vital role in ensuring timely, compliant, and accurate analysis of all incoming raw materials to support seamless site operations. This position offers the opportunity to work across a wide range of materials and analytical processes in a fast paced GMP environment, while contributing to product quality, regulatory compliance, and continuous improvement within the QC function.

Job Description

Requirements

• Sampling and analysis of materials (excipients, glass vials, caps, stoppers and USB components, packaging material)
• Retaining of samples for Chemistry and Packaging.
• Updating the Retain Database as required
• Actively involved in Investigations e.g. MQI’s, Vendor Complaints, LIR’s., MERTS and Trackwise items etc..
• Work with SAP for an optimal use of the system.
• Entering results on SAP, checking results are within specification and also task approval.
• Ensure compliance with EHS at all times, actively participate in EHS activities.
• Perform routine instrument calibration checks at appropriate times.
• Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times.
• Completion of Documentation for Batch Release process.
• Assisting in the provision of trends
• Support the Internal Audit Process..
• Generation/ reporting of Key performance indicators for the group.
• Be proactive in approach planning for future and implement improvements in an effective manner.
• Develop areas of expertise in analytical testing in order to solve technical issues.
• Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
• Interaction with other department’s e.g. BU, Engineering, QA, Validation etc..
• Keep colleagues informed of current issues and developments as appropriate.
• Assist in the training and up skilling of colleagues.
• Reasonable level of overtime will be required to facilitate the business needs.
• Liaising with internal and external customers e.g., planning/ QA/ Validation etc.
• Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.

Qualifications and Requirements

• A third level Science Qualification or equivalent
• Basic pharmaceutical experience in a GMP regulated laboratory environment.

Desired Skills

• Good communication skills, Flexibility and agility
• Openness to change and a proven ability to work on own initiative

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No