The company is a private equity sponsored, growth stage, specialty generic pharmaceutical organization focused on the development, manufacture and sale of products for the U.S. market with a secondary focus on international market(s), currently China.
The company strategy is to pursue the development of products that are challenging to formulate, manufacture and/or have a combination of barriers to market entry. The company’s differentiated formulation capability is one key of several elements of the company’s strategy.
- Maintain all controlled documents both electronically and on the company’s intra-department server and manually in the QA document record center for US operations;
- Coordinate the archival and retention of all GMP related documentation.
- Develop and maintain databases for all Quality documentation and training for the US site.
- Initiate internal Quality documentation such as deviations, change controls, CAPAs, etc and track them to ensure their timely closure;
- Assemble and review documents for completeness and accuracy and distribute to required reviewers/approvers;
- Assemble and distribute draft documents and training records for all affected departments;
- Maintain a list of distributed documents, with the associated location and owner;
- Manage and develop document templates and formats that comply with government regulatory and company standards;
- Create Policies and SOPs as needed in conjunction with all internal departments.
- Assist with retrieval of documents as part of daily operations, management review meetings and other specified documents as needed,
- Providing guidance on document control practices and procedures to all departments;
- Aid in qualification of any newly implemented documentation and QMS systems.
- Perform additional tasks as needed.
Desired Skills &Experience
- 5-10 years documentation and training experience in the pharmaceutical industry
- Self-motivator, good time management skills, excellent organization skills, good inter-personal skills
- HS Diploma with 10 years or more experience in the pharmaceutical industry
- AA/AS Degree with 8years or more experience in the pharmaceutical industry
- BA/BS Degree with 5 years or more experience in the pharmaceutical industry