Director of Sterility Assurance
hace 1 mes
We are looking for a Director of Sterility Assurance to join our client in Guadalajara, Mexico. Our client has over 75 years of experience and is a commercial organization focused on the development, manufacturing and sterilization of complex medical device and pharmaceutical products.
This role will ensure product quality, patient safety and regulatory compliance, provide executive management towards the management of sterility assurance and contamination control of injectable production, establish guidelines for sterility assurance and contamination risk mitigation, develop a holistic culture of continuous improvement focused on sterility assurance and contamination control, act with a commitment to maintaining the highest standards in the pharmaceutical manufacturing of injectable drugs
**Responsibilities**
- Develop, implement and drive contamination control and sterility assurance strategy for injectable products manufactured at the site. In addition to establish strategy to minimize risks of regulatory non-compliance and act in an integrated manner with the various site departments in identifying and mitigating risks associated with sterility assurance throughout the manufacturing process.
- Collaborate cross-functionally with various departments such as quality control, quality assurance, manufacturing, research and development, and regulatory affairs acting as a bridge between these functions, fostering communication and ensuring that sterility concerns are integrated into all stages of the product lifecycle.
- In close collaboration with the operations areas (microbiological laboratory, validation, manufacturing, quality assurance, etc.), define, implement and maintain strategies for (1) simulated filling program; (2) training and coaching of personnel involved in the manufacturing process on best practices for maintaining sterility through a proactive approach so as to build a quality culture that reinforces the importance of sterility throughout the organization, (3) perform periodic GEMBA-style assessments of manufacturing operations, including identification of deficiencies, risks and opportunities for improvement, (4) contribute to process optimization by implementing best practices and advanced technologies in manufacturing, testing and validation, (5) establish uniform usage strategy, site cleaning and disinfection program, (6) review and approve validation procedures, assessments, investigations and reports, (7) monitor, evaluate and improve sterility assurance processes over time, ensuring that the organization keeps abreast of industry developments and adapts to evolving regulatory requirements and (8) ensure that injectables manufactured at the site are free of microbial contamination and meet the specifications required at its highest standards.
- Monitor and review microbiological data for trends, as well as lead complex investigations into issues affecting sterility assurance (i.e. adverse environmental monitoring trends, simulated fill failures, etc.), establish appropriate and preventative response plans to environmental events in cleanrooms, provide technical guidance on any contamination related non-conformances or events and if necessary work closely with regulatory agencies to address concerns promptly. Promote a culture of continuous improvement in all areas related to sterility assurance.
- Interact directly with FDA, other regulatory agencies and auditors on all issues related to sterility assurance. This includes supporting preparation for customer inspections, health authorities and/or responding to observations during audits.
**Qualifications and Experience**
- Bachelor’s Degree plus a 10 years experience in FDA regulated environment - US 21 CFR Part 210 & 211 Current Good Manufacturing Practice. Experience in dealing directly with FDA.
- Previous leadership/management experience in the pharmaceutical/biotechnology industries performing quality control microbiology testing, release testing and coordinating the activities of a microbiology laboratory.
- Practical experience in aseptic manufacturing operation.
- Experience in Out-of-Specification (OOS), Out-of-Trend (OOT) and Out-of-Expectation (OOE) support/writing and/or deviation investigations.
- Knowledge in microbiology laboratory operation, contamination control program, environmental monitoring, aseptic process simulations (simulated fills), engineering controls for clean room operations and critical systems (i.e. process air, water for injection, etc.), knowledge of FDA cGMP and ISO 14644-1 standards.
- Strong research skills, preferably familiar with root cause analysis methods and excellent technical writing skills.
- Expertise in aseptic techniques, cleanroom behavior and practice, cleaning methodologies and risk assessments.
- Good knowledge of the drug manufacturing process, from development, technology transfer, commercial production, quality control and all related regulatory aspects.
- Pharmatech Associ
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