Quality Assurance Manager
2 months ago
Job Description Quality Assurance Manager:
The Manager of Quality Assurance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Your responsibilities will include managing all Quality Assurance aspects of compounding sterile pharmaceuticals for compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the manager over the QA operations/staff, coordinating day to day functions. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
Responsibilities:
All responsibilities as defined below apply to 503B operations and quality systems:
• Manage Quality Assurance activities to ensure that procedures are followed and to oversee various aspects of production so that a quality drug product is produced. This includes product safety, strength, identity, purity, and potency as well as microbiological quality for sterile products.
• Responsible for periodic review of records to evaluate the quality standards for each drug product to determine the need for changes in specifications or control procedures. As part of this review, the Manager will identify trends and evaluate quality indicators.
• Manage final review and approval of all cGMP documentation (SOPs, Instructions, Protocols, Specifications, Forms, Master Batch Records, etc.)
• Responsible for maintaining electronic and paper master batch record process steps and approval.
• Manage disposition of batch documentation for manufacture products.
• Ensure communication and manage product release with Operations to ensure availability of product in a timely manner.
• Ensure employee Qualification programs for 503B activities are maintained and general training is current.
• Manage review and approval of unexpected results or failures, environmental & personnel monitoring results that exceed alert or action limits, and direct resulting improvement activities.
• Provide Review, Impact Assessment, and Approval of Changes according to Xseer Change Management.
• Ensure Quality Systems are aligned with current Good Manufacturing Practices (e.g. all aspects of the facility lifecycle are compliant with industry expectations / cGMP).
• Participate in, and assist with, regulatory inspections as applicable to the 503B Operation and Quality Systems.
• Responsible for maintaining QA records associated with internal and external testing.
• Understanding of process flows, gap assessments and analysis of data to drive improvement.
Qualifications:
• Minimum four year college degree in Engineering or Life Science.
• Preferred 4 years of experience in pharmaceutical Quality Assurance with focus on cGMP compliance.
• Past experience and understanding of the 503B industry and cGMP requirements as they apply to Section 503B of the FD&C Act.
• Experience in quality systems with proven science-based decision-making skills.
• Thorough knowledge of cGMP, FDA, USP and pharmacy state board regulatory guideline.
• Strong interpersonal/group skills with ability to motivate and direct the Strong communication skills, verbal and written Proficiency with basic computer skills (i.e. word processing, spreadsheets, etc.)
KB 3/8/2024
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