Quality Control Head
If you are passionate about the pharmaceutical sector, have experience as a QC Head, and enjoy challenges, this is the opportunity for you. We look forward to seeing you!
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About the client:
A leading global pharmaceutical multinational is actively looking for a Quality Control Head.
Job main goals:
The QC Head will lead the Quality Control Department, overseeing the analysis, validation and method transfer activities in compliance with Good Manufacturing Practices closely collaborate with R&D, production and regulatory teams to ensure release of safe, effective and compliance pharmaceutical products, and will be the primary point of contact for all quality-related issues, both internally and with regulatory agencies, especially during the certification and inspection of the lab by the Spanish Agency.
1. Key responsibilities
Leadership & Strategy:
- Develop and execute the QC strategy to ensure products meet regulatory and company quality standards.
- Lead, mentor, and manage the QC team, ensuring proper training in analytical techniques, compliance, and reporting.
- Provide leadership in internal and external audits and inspections, including preparation, responses, and follow-up actions.
QC Processes and Documentation
- Oversee the development, implementation, and continuous improvement of QC protocols, SOPs, and testing methods.
- Ensure adherence to Good Manufacturing Practices (GMP), ISO standards, and all regulatory requirements related to pharmaceutical quality control.
- Oversee all product testing, including chemical, physical, microbiological, and stability testing, ensuring products meet purity, potency, and safety standards.
- Ensure the proper calibration, maintenance, and qualification of QC laboratory equipment.
- Ensure accurate and timely documentation of all QC activities, including analytical reports, certificates of analysis (COAs), deviation reports, and other quality records.
- Monitor and report on key quality metrics, providing actionable insights to management.
- Lead investigations into product defects, deviations, and out-of-specification (OOS) results, ensuring corrective and preventive actions (CAPAs) are implemented.
Cross-functional Collaboration:
- Work closely with R&D, production, and regulatory affairs to align on product quality goals and to troubleshoot any issues
- Lead the QC team's support for technology transfer, process validation, and method validation efforts.
Regulatory Compliance:
- Stay updated on all relevant industry regulations (EMA, FDA, ICH, etc…) and ensure the QC department's practices remain compliant.
- Lead regulatory inspections and ensure readiness for any audits, providing necessary documentation and responses to authorities and clients.
2. Core Competencies:
- Attention to detail and a commitment to quality
- Analytical and critical thinking skills
- Excellent communication, problem-solving, and decision-making skills.
- Ability to prioritize workload
3. Qualifications:
- Bachelor’s or master’s degree in pharmacy, Chemistry or a related field.
- Minimum of 8 years of experience in Quality Control within the pharmaceutical industry.
- In-depth knowledge of GMP, ICH guidelines, EMA regulations, and other relevant pharmaceutical industry standards.
- High level of English, written and spoken
4. Preferred experience:
- Experience with regulatory audits and inspections (EMA, FDA).
- Proficiency in QC software and laboratory information management system (LIMS).
- Department
- Pharma & Medical Devices & Chemicals
- Role
- Quality
- Locations
- Barcelona
- Remote status
- Hybrid Remote
- Employment type
- Full-time
Quality Control Head
If you are passionate about the pharmaceutical sector, have experience as a QC Head, and enjoy challenges, this is the opportunity for you. We look forward to seeing you!
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