Compliance Manager
Company: Disability Solutions
Location: Saint Petersburg
Posted on: April 19, 2024
Job Description:
Position 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.The Role
- Enforce Computerized System Validation (CSV) guidelines,
policies, and procedures for control systems, automation,
analytical equipment, and IT applications.
- Ensuring 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.
- Collaborate on the maintenance of local policies and
procedures.The Candidate
- Bachelor's degree in computer science, other STEM related
field
- 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
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
offers rewarding opportunities to further your career!-- Join the
global drug development and delivery leader and help us bring over
7,000 life-saving and life-enhancing products to patients around
the world. Catalent is an exciting and growing international
company where employees work directly with pharma, biopharma and
consumer health companies of all sizes to advance new medicines
from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one
will be used by someone who is counting on us. Join us in making a
difference.--Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------personal initiative. dynamic pace. meaningful
work.Visit to explore career opportunities.Catalent is an Equal
Opportunity Employer, including disability and veterans.If you
require reasonable accommodation for any part of the application or
hiring process due to a disability, you may submit your request by
sending an email, and confirming your request for an accommodation
and include the job number, title and location to . This option is
reserved for individuals who require accommodation due to a
disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will
provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Lake Magdalene , Compliance Manager, Executive , Saint Petersburg, Florida
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