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Compliance Manager - Saint Petersburg Florida
Company: Disability Solutions Location: Saint Petersburg, Florida
Posted On: 05/17/2024
Compliance ManagerPosition SummarySt. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. --The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. --Non-gelatin based OptiShell-- and Vegicaps-- capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects including but not limited to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations, Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of the Quality Unit and could include all or some aspects of the Quality function.The Role - Enforce Computerized System Validation (CSV) guidelines, policies, and procedures for control systems, automation, analytical equipment, and IT applications.
- Ensure that GxP systems comply with all applicable GxP, legal, and fiduciary policies, practices, and requirements.
- Collaborate with manufacturing, engineering, validation, information systems, QA, QC, and training to provide training and coaching on CSV projects and data integrity initiatives.
- Develop and execute plans, procedures, and requirements to address data integrity gaps for GxP systems and assuring compliance for the site.
- Identify data integrity risks and propose improvement plans. This includes identifying data and systems issues, defining requirements, and recommending enhancements for system features and related processes.
- Assist in development of site related data integrity training materials to provide guidance, training, and support to site personnel.
- Participate as DI SME in deviation management investigations, CAPA, and effectiveness check processes for continuous improvement and inspection readiness.--
- Assess changes to GxP systems and data integrity regulatory requirements and communicate requirements to site leadership.
- Review and approve change controls related to local GxP systems.
- Review and approve periodic reviews of local GxP systems.
- Other duties as assignedThe Candidate
- Bachelor's degree in computer science, other STEM related field is required.
- In lieu of bachelor's degree, a minimum of 5 years of Quality or IT role supporting GxP systems and 7+ years total relevant experience will be considered.
- Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP experience preferred.
- Strong interpersonal, communication and problem-solving skills.
- Creative and innovative ability.
- Ability to work effectively under pressure and comply with timelines.
- Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
- Professional with strong interpersonal skills.
- Strong verbal and written communication skills; good presentation skills.
- Regularly applies theories and principles for one's technical discipline
- Works independently to solve problems of moderate scope
- Actively participates and suggests solutions to problemsWhy You Should Catalent
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