Quality Assurance Associate

PE Global; Cork; On-site; EUR 45,000 - 60,000; Full time

Benefits offered by this job

Shift premium

Job summary

PE Global is recruiting a QA Associate for a leading pharmaceutical company in Cork on a 12-month contract. The role reports to the QA Operations Manager and covers start-up through routine QA support, with a focus on promoting quality across cross-functional teams and ensuring on-time, high-quality processes.

The candidate will oversee start-up QA activities, CAPAs, deviations, and Lot Release input, contributing to GMP compliance and continuous improvement.

Qualifications

• Degree or 3rd level in Science or Quality; QP qualification is an advantage.
• Experience in Sterile Drug Product Filling and startup environment.
• 5+ years of quality function experience in pharma/biotech.
• Knowledge of FDA/EMEA regulations and quality systems.
• Proficient in Excel, Word and PowerPoint.
• Ability to work independently and lead small projects.
• Strong communication and problem-solving skills.

Responsibilities

• Provide QA direction for start-up, tech transfer, operation and continuous improvement of Sterile Drug Product Filling.
• Provide QA input to Change Controls, Protocols, Reports and related documentation.
• Write, review and approve SOPs, Work Instructions, QTA, Master Batch Records and specifications.
• Collaborate across departments to keep projects on schedule and compliant.
• Lead CAPAs and Deviations with robust root-cause analysis and action plans.
• Support regulatory inspection readiness and new product launches.

Skills

Sterile Fill

Quality Assurance

Root Cause Analysis

Regulatory Knowledge

MS Office

Communication Skills

Independent Working

Education

Science/Quality Degree

QP Qualification

Tools

Excel

Word

PowerPoint

Job description

PE Global is currently recruiting for a QA Associate on behalf of a leading pharmaceutical company based in Cork. This is an initial 12 month contract.

***This is a 3 cycle shift position, covering days and nights.

Shift premium applies to shift hours worked.***

Job Description:

This role (which reports to the QA Operations Manager) will provide QA support for the start-up of the facility, before moving into routine QA support of same.

The successful candidate will also have proven capability in promoting Quality across cross-functional teams, to deliver on-time high-quality processes and products, whilst ensuring continuous process improvement.

Responsibilities:

• Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with Policies.
• Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
• Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
• Provide Quality input and guidance to ensure Lot Release (Components/Raw Materials/Drug Product) of high-quality products in compliance with current Good Manufacturing Practices (GMPs).
• Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
• Provide Quality input to Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
• Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
• Pro-actively identifies compliance risks and takes appropriate preventative actions.
• Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues.
• Ensure high level of Quality / cGMP Awareness in the Project Team and Sterile Filling Team.
• Lead Area GMP Certification Activities.
• Support pre-approval Regulatory Inspection readiness to ensure regulatory approvals are obtained.
• Support all Quality Assurance elements needed to facilitate new product launches.

Education and Experience:

REQUIRED:

• Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
• Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
• Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels.
• Strong organizational skills, including ability to follow assignments through to completion.
• Proficiency in PC skills such as Excel, Word, PowerPoint.
• Proven decision-making capability with full accountability and responsibility.
• Demonstrated coaching skills.
• Excellent written and verbal communication skills.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.

DESIRED:

• Experience in Sterile Drug Product Filling and start-up of same.
• Evidence of Continuous Professional Development.
• Evidence of Validation knowledge/experience.
• MES experience.
• Good knowledge of Lean / Continuous Improvement practices and root cause analysis.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***