What are the responsibilities and job description for the Surmasis Pharmaceutical - Director of Quality | M-F | Pay Based on Experience position at katecho?
Job Description:
SUMMARY
Directs all quality functions at Surmasis to assure that all products manufactured by the organization meet customer specifications and regulatory requirements and achieve superior quality and reliability levels. This position is hands-on and very involved in the day-to-day operations of the Quality Department functions of Surmasis as a 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
- Acts as a key contributor to the overall quality direction of the company. Communicates and works together with other management at Katecho to maintain and improve the direction of the company.
- Develops and implements the quality assurance and quality control programs at Katecho to ensure conformity of processes to established quality standards.
- Maintains a high level of understanding of relevant production processes and quality systems related to 21 CFR 210/211 and Part 820 (applicable sections for combination products).
- Reports to management on the performance of the QMS and the avenues for improvement.
- 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.
- Facilitates 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.
- Oversees Supplier Management, including but not limited to, Annual Assessments, Quality Assurance Agreements, and KPI’s.
- Collaborates in data analysis and report creation on quality metrics and key performance indicators.
- Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance are crucial for efficient plant operations, safety, and morale.
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.