Catalent Pharma Solutions (a Blackstone Group company) is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 20 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.
Specific Duties, Activities, and Responsibilities:
- Initiation, investigation and responding to customer complaints
- Compiling and generation data in support of Annual Product Reviews (APRs) for all commercial customers.
- Metric/dashboard maintenance; includes collecting data, producing graphs/charts/summarizing data and merging into uniform templates for management and senior management.
- Regulatory Affairs Department and complaint handling associated with internal storage as well as coordination with off-site storage facility.
- Maintain effectiveness of the Quality System.
- Other duties as assigned.
Education or Equivalent:
- Minimum High School Diploma, Associates Degree preferred.
- 1-3 years Regulatory Affairs experience in the pharmaceutical industry
- High level of attention to detail.
- Strong problem solving and analytical skills.
- Works well under pressure and able to prioritize workloads.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Review reports, etc. for accuracy.
- Must be able to perform risk assessments in a timely manner and act accordingly. Successful candidate will possess strong computer and appropriate communication skills (both written and oral) allowing direct interaction with outside suppliers, STW internal Managers and Sr. Management.
- Should be familiar with cGMP and safe work practices.
- Demonstrated ability to read, write, and speak clear English.
- Frequent sitting, walking, reading of written documents and use of computer monitor screen, writing, talking, carrying, listening
- Occasional lifting and/or moving up to 30 pounds
- Performance driven
- Customer focused
- Collaborative and inclusive
Catalyst + talent = Catalent. At least, that's the brand Catalent Pharma Solutions is using to try to ensure its customers'...