Key Responsibilities:

• Oversee day-to-day management of GMP paperwork, including reviewing and approving logbooks, analytical raw data, environmental monitoring reports, and other documentation.
• Support QA activities within the Warehouse, production areas, QC laboratories, and facility/utility spaces.
• Assist with regulatory and customer inspections/audits as required.
• Develop, review, and update Standard Operating Procedures (SOPs) to support business needs while ensuring compliance with regulatory requirements.
• Maintain and enhance QA operational performance in alignment with regulatory authorities, global standards, and company SOPs.
• Implement and monitor quality assurance activities to ensure compliance with FDA/EU regulations, including cGMP standards for commercial medicinal products and clinical materials.
• Demonstrate knowledge of cGMPs, specifically 21 CFR Parts 11, 210, 211, and 600.
• Utilize ERP systems such as Maximo, Veeva, and SAP to support quality assurance functions.
• Ensure appropriate escalation and follow-up for non-conformities in laboratories and utility areas, including issuing deviations when necessary.
• Collaborate with cross-functional teams to achieve business objectives while maintaining compliance.
• Stay updated with USP/EP, ICH guidelines, and QC methodologies to ensure compliance with current testing and specifications.
• Perform additional duties as assigned by management, with the necessary training and guidance.

Skills & Competencies:

• Strong knowledge of cGMPs: 21 CFR Parts 11, 210, 211, and 600.
• Experience with quality assurance activities in laboratory and facility environments.
• Expertise in ERP systems like Maximo, Veeva, and SAP.
• Excellent communication skills, both written and verbal.
• Customer-focused with strong analytical and problem-solving abilities.
• Proficient in project management and capable of prioritizing tasks effectively.
• Attention to detail with the ability to work accurately in a demanding environment.
• Self-motivated and proactive with a hands-on approach.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).

Education & Experience:

• Bachelor's degree in biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry, or a related scientific field, or equivalent work experience.
  * 3+ years of GMP pharmaceutical experience in a quality assurance or quality control role (1+ years if holding a Master's degree).
  * In-depth knowledge of cGMPs, including 21 CFR Parts 11, 210, and 211; knowledge of 21 CFR 600 for biologics is desirable.