Quality Assurance Manager
VP of Quality
Quality Assurance Specialist
This position is hands-on and very involved in the day-to-day operations of the Quality Assurance functions of the Pharmaceutical Drug contract manufacturer. Products within the scope of the company include, but are not limited to, topical/transdermal products, such as patches, creams, lotions and ointments. Activities of the job may include, but are not limited to, batch releases, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management and regulatory interactions, either directly or through direct reports.
PRIMARY DUTIES AND RESPONSIBILITIES
- Maintains a high level of understanding of relevant production processes and quality systems related to 21 CFR 210/211.
- Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Change Requests, Batch Records and associated documentation, Product and Component Release, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, Standard Operating Procedures
- Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
- Facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
- Collaborates in data analysis and report creation on quality metrics and key performance indicators
- Accountable for Supplier Management including but not limited to Annual Assessments, Quality Assurance Agreements, and KPI’s.
SECONDARY DUTIES AND RESPONSIBILITIES
- Strong collaboration with the other regional and global sites to ensure consistent application of quality systems / processes across the site..
- Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
- High level of proficiency in problem solving, creativity, independent thought, and sound judgment.
- Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
- Training and mentoring of other members of the organization.
- Strong performance history of consistently meeting and exceeding expectations.
- Other duties and responsibilities may be assigned as required.