Position: QA Specialist (PRD) – Investigations, CRs, CAPAs & Floor Oversight
Location: León (on-site)
Experience: At least 3 years in similar roles within the Quality department in pharmaceutical industrial settings.
General Responsibility
Ensure quality oversight of production-related activities in a GMP-regulated manufacturing environment, acting as a key quality partner for operations on the shop floor. The role is responsible for leading and coordinating investigations, change controls and CAPAs, ensuring appropriate risk assessment, impact evaluation and timely closure in compliance with quality and regulatory requirements. In addition, the position provides real-time QA support to production, reinforcing GMP compliance, issue resolution and continuous improvement across daily manufacturing operations.
Specific Responsibilities
* Lead and manage quality investigations related to deviations associated with production activities.
* Perform and support root cause analysis, ensuring robust identification of underlying causes and appropriate documentation of findings.
* Evaluate the impact of deviations on product quality, manufacturing processes and GMP/regulatory compliance.
* Coordinate cross-functional investigation activities with Production, Engineering, Quality Control, Maintenance and other relevant departments.
* Review, assess and approve change requests/change controls, ensuring proper justification, impact assessment and implementation in line with GMP requirements.
* Ensure that change controls are adequately evaluated, approved, implemented and closed within established timelines.
* Review and approve CAPA plans derived from investigations, audits and inspections, ensuring actions are appropriate and sustainable.
* Monitor CAPA implementation and verify effectiveness prior to closure.
* Provide routine QA floor oversight through regular presence in production areas, supporting real-time decision-making and compliance with approved procedures.
* Support production teams during critical operations, helping resolve GMP issues promptly and reinforcing quality culture on the shop floor.
Experience (area)
Quality Assurance in GMP-regulated pharmaceutical or biotechnology manufacturing environments, with strong exposure to production-related quality activities.
Personal skills
* Adaptability to change and flexibility
* Speed without compromising on quality
* Leadership and teamwork
* Effective communication
* Compliance, integrity and sustainability
* Growth mindset
* Business focus
Our benefits
* Permanent contract
* Career progression and development within a growing international group
* Ongoing training and an innovative working environment
* Subsidised canteen and other employee benefits
Equal Opportunity Statement
COMMITMENT TO EQUAL OPPORTUNITIES AT LEONFARMA, we believe in and act to promote genuine equality of opportunity. We do not discriminate on the basis of gender, ethnicity, religion, sexual orientation, disability or any other characteristic. We value diversity and talent.
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