Essential Duties and Job Functions:
- Prior experience in the Pharmaceutical Industry is required
- QC background is essential, e.g. experience regarding equipment qualifications, analytical method transfers and technical issues within QC
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures to ensure quality objectives are met.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- May assist with compliance audits as required.
- Interfaces with contract manufacturers to address documentation and compliance issues.
- Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
- Normally receives no instruction on routine work, general instructions on new assignments
Knowledge, Experience and Skills:
- Demonstrate proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Proficiency in application of QA principles, concepts, industry practices, and standards.
- Thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
- Strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
- Demonstrate audit and investigation skills, and report writing skills.
- Strong verbal, technical writing and interpersonal skills.
- Proficiency in Microsoft applications
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists