QA Validation Specialist
3 weeks ago
Quality Assurance Specialist
Client: Large Healthcare Company
Location: Millburn, New Jersey
Duration: 1 year contract with likelihood of extension
Benefits: Health, Dental, & Vision
Project Goal & Overview:
Novartis is seeking a seasoned QA (Quality Assurance) Validation Specialist to support the strategic implementation of quality and validation objectives. This individual will play a critical role in ensuring that all pharmaceutical products meet rigorous quality standards and regulatory requirements, contributing to the safe and effective delivery of products to patients. We are looking for this person to be a strategic thinker, great team player, and a true problem solver.
Deliverables/Milestones:
- Spearhead the development, manufacturing, and distributing of products, ensuring all activities meet established quality standards and regulatory expectations.
- Ensure compliance with relevant regulations, guidelines, and standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
- Develop, implement, and maintain quality management systems to support product quality and validation objectives.
- Establish and maintain standard operating procedures (SOPs) for quality-related processes, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions) systems.
- Review and approve batch records, analytical data, and associated documentation to ensure compliance with specifications and regulatory requirements.
- Provide oversight and support for quality assurance activities throughout the product lifecycle, including manufacturing, packaging, labeling, and distribution.
- Conduct risk assessments and participate in the evaluation of suppliers, contractors, and vendors to ensure compliance with quality standards and regulatory requirements.
- Lead or participate in continuous improvement initiatives to enhance quality processes, efficiency, and effectiveness.
Qualifications:
- Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific field required.
- Minimum 3-5 years of experience in Pharmaceutical Manufacturing, Quality Assurance, and Quality Control required.
- Minimum 3-5 years of experience with Computerized System Validation (CSV), Equipment Validation, and/or Process Validation required.
- Thorough understanding of pharmaceutical regulations and quality standards, including GMP, GLP, and GDP.
- Experience with quality management systems, document control, and auditing processes.
- Experience in aseptic manufacturing processes and techniques required.
- Proficiency in overseeing product production processes, including packaging, labelling, and distribution, to ensure compliance with quality standards and regulatory requirements.
- Strong analytical skills and attention to detail, with the ability to interpret and apply complex regulations and requirements.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and levels of the organization.
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