À propos du poste
Fagron has an immediate opportunity at the FSS facility for a QA Compliance Manager to work under the direction of QA Director in a DEA and FDA-regulated environment. This position supports validation of Pharmaceutical Manufacturing Equipment Control Systems and Enterprise Resource Planning (ERP) applications.
• Supports and facilitates audits and regulatory inspections.
• Develops, improves, and monitors Quality Systems for the entire organization.
• Continuously improves areas impacted by deviations and approves appropriate CAPAs.
• Write and revise standard operating procedures (SOPs).
• Provides direction and oversight during active processes and applies understanding of FDA regulations (21 CFR 11, 21 CFR 820), FDA Quality Systems and Continuous improvement.
• Able to independently organize and perform own work tasks and assist coordinating activities to support production schedule thru other co-workers.
• Correct weaknesses, ineffective procedures, policy exceptions and discrepancies and performs or approves appropriate corrective actions followed by effective rates with the aim of being able to offer optimum quality control and quality guarantees.
• Provides Training to new employees.
• Able to work effectively with team members and other professionals such as vendors, contractors, or suppliers with the aim of ensuring their products or services meet the organization’s quality standards.
• Proficiency with Microsoft applications, including Word and Excel and environmental systems.
• AS, BS degree and/or equivalent experience in Chemistry, or related discipline.
• 5 + years experiences with environment monitoring and process.
• Experience of FDA CFR 210 and 211.
• In depth knowledge of the pharmaceutical industry, sterile compounding preferred.
• Experience working in cGMP environments meeting FDA, OSHA, DEA guidelines, local regulations, and industry best practices.
Profile and Experience:
• Experienced leader, motivator, communicator and coach with a strong sense of working in a team environment.
• Excellent planning and organizational skills and ability to balance manufacturing and quality system requirements.
• Experience writing exception reports and drive CAPAs to completion.
• Proficient time manager with good communication, verbal, and writing skills.
• Understanding of environment monitoring and application of appropriate solutions.
• Experience in conducting and/or directing internal investigations of data integrity compliance issues.
• Ability to clearly disseminate written policies and procedures related to sterile environment requirements.
• Map bottlenecks and report solutions to management with the aim of discovering abnormalities when complying with quality standards within the organization.
• Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management).
• Knowledge of GMP including international regulations.
• Knowledge of applicable parts of 21 CFR regulations.
• Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.
• Good verbal and written communication skills
• Compliance and ANDA, NDA filing will be a plus.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.