Responsible for daily Quality Assurance activities and GMP compliance relating to the baseline Quality Systems of Documentation, Change Control, Deviations, APR and Investigations in support of manufacturing, packaging and distribution of marketed and development drug products.
Provide oversight of the use of the Quality Systems and maintains their currency with current regulatory requirements and industry best practices.
PRINCIPAL ACCOUNTABILITIES (Describe in a series of brief statements up to five of your primary job responsibilities or activities in descending order of importance.) 1. Establish and maintain Quality Systems for Documentation, Change Control, Deviations, APR and Investigations in support of marketed and development products. Ensure these systems result in quality and cGMP compliant products. Ensure compliance with current regulatory expectations, Purdue policies and procedures, and industry best practices. Anticipate changes in regulatory thinking in relation to areas of responsibility. Responsible for notifying senior management of Quality Operations of any compliance deficiencies or concerns in a timely manner. 2. Provide leadership, assistance and guidance while fostering teamwork and timely, effective communication during daily operations to assure cGMP compliance. 3. In collaboration with the Wilson Quality Leadership team and internal customers continue to improve the functionality, effectiveness and efficiency of the procedures and systems supporting operations. 4. Lead the function, develop team members, and provide support to the internal groups who utilize the systems and procedures which support the Quality Systems.. 5. Perform other related assignments and duties as required and assigned. 6. Demonstrated ability to manage several projects simultaneously and to address unexpected results.
Educational Requirements Minimum of a Bachelor#s degree in a related Science is required.
Required Experience & Technical Requirements Minimum of 10 years of experience within a regulated pharmaceutical environment; or a graduate degree with 8 years# experience. # Demonstrated thorough knowledge of quality processes and compliance with specific emphasis on Deviations, Investigations, Change Control, Annual Product Reviews and GMP Documentation. # Demonstrated ability to act as a functional expert. # Proficiency in Root cause analysis, trend analysis, process improvement and process capability. # Ability to negotiate needed actions and manage difficult interactions effectively. # Strong oral and written communication skills. # Knowledge of computerized support tools and software for support of Quality Systems. # Demonstrated thorough knowledge of quality processes and good technical understanding of solid dose manufacturing processes and equipment. # Ability to act as a functional expert although may need to seek guidance on complex issues. # Demonstrated initiative to seek additional responsibilities.
Ms. Angela Kearney Recruiter
Mr. Joshua Thompson Recruiter
Purdue Pharma - 21 months ago
Purdue Pharma helps bring patients relief from pain. The company specializes in developing, manufacturing, and marketing prescription and...