Responsibilities
- Manage and maintain the certified supplier list, ensuring all records are current and aligned with quality risk assessments.
- Ensure compliance with operational standards from US and international regulatory agencies, including FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, and cGMP.
- Act as the site auditor for suppliers, ensuring adherence to audit schedules and quality standards.
- Lead and manage the supplier change control process, handling notifications and changes.
- Submit SCAR (Supplier Corrective Action Report) deviations for defects identified in supplier-provided materials.
- Provide regulatory support during FDA and other agency on-site audits.
- Serve as the sites Quality Subject Matter Expert (SME) on MSD (Manufacturing Site Division).
- Coordinate and oversee internal and external supplier audits to ensure quality and compliance across the supply chain.
- Investigate and resolve quality issues, including non-conformances, out-of-specifications, and deviations, ensuring corrective actions are implemented effectively.
- Collaborate with cross-functional teams (e.g., manufacturing, regulatory, and R&D) to maintain product quality and address quality-related concerns.
- Review and approve quality-related documents, including validation protocols, certificates of analysis, and test reports.
- Ensure the timely review and closure of quality investigations, ensuring compliance with company standards and regulatory requirements.
- Provide training and guidance to staff on quality systems and compliance procedures, fostering a culture of quality awareness throughout the organization.
Qualifications
- Bachelors degree in Biology, Chemistry, or a related field.
- Minimum of 3 years of relevant industry experience, with a preference for experience in exception investigations and out-of-specification resolutions.
- Strong ability to conduct Root Cause Analysis, resolve conflicts, and make decisive, effective decisions under pressure.
- Results-driven, with the ability to manage and prioritize multiple projects simultaneously.
- Proficiency in Microsoft Office Suite and other relevant computer programs for data entry and reporting.
- Strong analytical, problem-solving, and decision-making skills, with a hands-on approach.
- Excellent verbal and written communication abilities, with the capacity to work independently or collaboratively as needed.
- High energy and consistent attendance, ensuring dedication to tasks and deadlines.
- Thorough working knowledge of cGMP guidelines, with proven application in a pharmaceutical manufacturing environment.
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