Remote Pharmaceutical Quality Assurance Specialist

About the Role

This is a unique opportunity to join Our client, a forward-thinking pharmaceutical company, in a fully remote capacity as a Pharmaceutical Quality Assurance Specialist. We are expanding our Quality Operations team and are looking for a meticulous and experienced professional to ensure that our pharmaceutical products meet the highest standards of quality and regulatory compliance. You will be instrumental in developing, implementing, and maintaining robust quality management systems that govern all aspects of our drug development and manufacturing processes. This role requires a proactive approach to identifying potential quality risks and implementing effective mitigation strategies. As a remote team member, you will have the autonomy to manage your workload effectively while contributing significantly to Our client's commitment to excellence and patient safety from your own dedicated workspace. Your expertise will directly contribute to upholding the integrity and reputation of Our client's pharmaceutical offerings on a global scale.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with international pharmaceutical standards (e.g., GMP, ISO).
• Conduct internal and external audits of manufacturing sites, suppliers, and service providers.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Investigate deviations, out-of-specifications (OOS), and customer complaints, implementing corrective and preventive actions (CAPAs).
• Monitor and analyze quality metrics, providing regular reports to senior management.
• Ensure compliance with global regulatory requirements, including those from agencies like the FDA and EMA.
• Develop and deliver training programs on quality assurance principles and procedures.
• Participate in regulatory inspections and client audits.
• Contribute to the continuous improvement of quality processes and systems.
• Manage change control processes effectively.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 4 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of Good Manufacturing Practices (GMP) and relevant regulatory guidelines.
• Proven experience in conducting audits and managing CAPA systems.
• Excellent understanding of pharmaceutical manufacturing processes and product lifecycle.
• Strong analytical and problem-solving skills.
• Exceptional attention to detail and accuracy.
• Proficiency in quality management software and standard office applications.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Ability to work autonomously and manage time effectively in a remote setting.

Benefits

This fully remote position offers a competitive salary and benefits package. Employees receive health, dental, and vision insurance, along with a retirement savings plan. Our client provides a professional development stipend for online courses and certifications, fostering continuous learning. You will have the flexibility to work from anywhere within designated regions, supported by a robust IT infrastructure. Opportunities for career advancement within a growing and innovative pharmaceutical company are abundant. We also offer generous paid time off and a supportive, collaborative virtual work environment that values work-life balance for our team members, irrespective of their physical location.

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