Job Title: QA Associate - Fill Finish
At BioMarin, we are a high-performing, team-based organisation where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organisational skills.
About the Role
This role will provide QA support for the start-up of sterile filling operations at the Shanbally facility and move into routine QA support of same. The successful candidate will have proven capability in promoting Quality across cross-functional teams, to deliver on-time high quality processes and products, whilst ensuring continuous process improvement.
Key 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 BioMarin Policies.
* Participate within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
* Prioritise tasks to ensure 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).
* Compile 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 judgement to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
* Proactively identify compliance risks and take 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 a 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.
Qualifications & Experience - Knowledge and Skills Requirements 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 realise 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 organisational 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.
Behaviours:
* Always focused on the patient and customer needs.
* Resilient profile with the ability to deliver in a challenging environment.
* Ability to engage and manage multiple stakeholders to achieve the objective.
* Curious with learning agility.
* Operationally excellent, with attention to detail.
* Organised with systematic approach to prioritisation.
* Process orientated to achieve the business objective.