Job Details
Level
Experienced
Job Location
Company Headquarters - Lexington, KY
Position Type
Full Time
Education Level
4 Year Degree
Job Shift
Day
Job Category
Pharmaceutical
Description
Summary:
Responsible for providing quality oversight during all stages of pharmaceutical development, manufacturing and testing.
Essential Duties:
Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and procedures
Leads the day-to-day activities of the QA group with respect to the writing, review and approval of GMP documentation.
Participate in all plant activities and leads continuous improvement objectives to ensure cGMP compliance.
Advises management on findings and recommendations related to internal and external auditing and implements changes
Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents.
Develops and maintains metrics and trending reports for Compliance-related activities.
Reviews and approves product complaint investigations and assists with investigations.
Leads activities associated with various one-time or on-going projects (from participation level to project manager).
Collaborates with departments and external suppliers regarding quality concerns.
Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
Leads regulatory inspections and customer audits.
Assists Manager with daily and project activities as needed.
Maintain current knowledge of new regulatory developments.
Other duties as assigned.
Qualifications
Bachelor degree in a scientific discipline
At least 9 years Pharmaceutical/Medical Device cGMP quality experience
Excels in organizational and leadership skills and attention to detail
Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
Familiar with the necessary components of facility qualification and validation activities.
Extensive knowledge of cGMP regulations and ICH guidelines.
Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners
Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
Qualified to work with controlled substances
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