Senior QA (Pharma)

Description

Job Summary: A Senior QA for GP Pharm, ensuring regulatory compliance (GMP, GxP, 21 CFR) and the quality of pharmaceutical batches. Key Responsibilities: 1. Lead investigations of deviations, OOS, and complaints. 2. Manage the lifecycle of process and cleaning validations. 3. Participate in audits and inspections by Health Authorities. **Senior QA (Pharma)** **Join GP Pharm as a Senior QA!** **Job Mission:** Ensure strict compliance with regulations (GMP, GxP, 21 CFR) and guarantee that every batch released from our facility meets approved specifications and established quality requirements. **What will you do daily?** As a Senior member of the Quality Unit, your responsibilities will focus on: * Quality Management System (QMS) Management: + Quality Events: Lead investigations of deviations, OOS, and complaints, ensuring robust root cause analysis and effective CAPA implementation. + Change Control: Evaluate the impact of proposed changes and oversee their correct implementation and closure. + Documentation: Review and approve quality system documentation. + Review of manufacturing and analytical procedures: Final review of batch documentation prior to release. * Validations (Process and Cleaning): + Manage the lifecycle of product process validations and aseptic fill validations (Media Fills). + Draft and/or review corresponding protocols and reports. * Data Analysis and Trending: + Prepare Product Quality Review (PQR) reports. + Monitor and evaluate quality KPI trends, environmental monitoring data, and water quality (WFI/PW). * Audits and Compliance: Participate in preparation for and execution of Health Authorities/customer audits and inspections, and follow up on resulting actions. The selected candidate will not manage all tasks; assignments will depend on experience and background. What are we looking for? * University degree in Pharmacy, Chemistry, Engineering, Biology, or Biotechnology * Minimum 3\-4 years of professional experience in a GMP environment within the Pharmaceutical Industry * English proficiency at least at FCE level Additional Information: * Location: Sant Quintí de Mediona (personal vehicle required) * Contract type: Permanent * Working hours: Flexible core hours * Flexible compensation **Why work at GP Pharm?** **GP Pharm Culture** At GP Pharm, our culture promotes equality, flexibility, and trust in people, prioritizing both professional and personal well-being. Our values guide everything we do and enable sustainable growth while always keeping patients, quality, and product efficacy at the forefront. **Mission:** Improve people's health and quality of life by manufacturing highly complex, accessible injectable products worldwide. Vision: Become the most reputable and reliable pharmaceutical company for our patients and partners, nationally and internationally, delivering the highest-quality injectable products through sustainable growth that reduces environmental impact. **Values:** **Achievement:** Our results-driven culture drives excellence. We set ambitious goals to ensure our products are effective and safe, and work agilely and methodically to deliver outcomes that exceed expectations. **Innovation:** We strongly champion innovation as a tool for continuous improvement. Research enables us to develop solutions that transform patients' lives and advance the pharmaceutical industry. **One Team:** At GP Pharm, we work as one team, fostering trust and communication. We share a common vision and collaborate to achieve our goals. Mutual respect and collective effort are essential to our shared success. **\#wearegppharm