Exercitation ullamco laboris nis aliquip sed conseqrure dolorn repreh deris ptate velit ecepteur duis.
People are the heart of our company, and we’re committed to fostering their success. We are looking for people with positive attitude and who are dedicated and can make an impact. If you are interested in learning more about a career at Saptalis Pharmaceuticals, please submit your resume directly to info@saptalis.com.
We are actively looking to fill the following positions:
Saptalis is looking to recruit a Regulatory Affairs Associate to join our team at our facility in Hauppauge, NY.
Regulatory Affairs Associate is responsible for preparation of all sections of regulatory filings. Strong understanding of computer software is required. Individual should have thorough understanding of regulatory requirements for pharmaceutical product development for the US market. Person should have excellent team work ethic and good written and verbal communication skills are required.
Send your resume to info@saptalis.com
Saptalis is looking to recruit a Manager, Regulatory Affairs to join our team at our facility in Hauppauge, NY.
Manager, Regulatory Affairs is responsible for regulatory submissions including ANDAs and NDAs. Provide necessary updates to submissions or responses to resolve any filing deficiencies. Review and approve all the required technical documentation to develop a product and successfully transition to commercial manufacture. Handle the post-approval regulatory activities such as filing annual reports and PADERs once the products are approved. Evaluate, advise, and approve regulatory impact of changes to manufacturing processes, specifications, and components. Coordinate external audits and inspections of the facility by regulatory agencies. Provide regulatory input for deviations, out of specifications (OOS) investigations, batch failures, and customer complaints. Supervise the implementations of pharmacovigilance program according to FDA requirements. Responsible for the development and implementation of quality system to describe how the firm complies with cGMPs and operates to maintain a state of control. Work with various tools such as eCTD software and SPL Editor. Excellent organization, verbal, written and documentation skills are required.
Send your resume to info@saptalis.com
Saptalis is looking to recruit R&D Administrative Assistant immediately to join the company at its facility in Hauppauge, NY.
This individual will assist in all administrative functions of the Company. Responsible for phone systems, copy machines and other office equipment. Will order, stock and maintain chemicals and laboratory supplies in appropriate storage areas, and keep those areas organized and clean. Will assist Document Control manager in compiling documents required for regulatory filings. Will receive visitors and supervise until conclusion of their visit to the plant. Assist the Regulatory Affairs and R&D in preparing protocols, reports, obtaining approval signatures for change controls, training documents etc.
Send your resume to info@saptalis.com
Saptalis is looking to recruit a QA Analytical Data Reviewer/Auditor to join the growing Quality group at our facility in Hauppauge, NY.
QA Data Reviewer/Auditor is responsible for GMP and technical review of method validations, raw material/in process/finished product/stability data for release. In addition, the responsibilities include supporting lab investigations, customer/agency audits and performing analytical testing as needed.
Send your resume to info@saptalis.com
Saptalis is looking to recruit Document Control Assistant to join the Document Control Group at our facility in Hauppauge, NY.
Document Control Assistant is responsible for assisting in managing GMP documentation preparation, distribution and archival. Individual should have good computer skills with Microsoft office Word, Excel etc.
Send your resume to info@saptalis.com
Saptalis is looking to recruit Analytical Scientists to join the growing Analytical R&D group at our facility in Hauppauge, NY.
Analytical Scientist is responsible for developing and validating analytical methods for analytes of interest in new drug products using UPLC, HPLC, GC and other analytical instruments. Execute all functions in accordance with current FDA regulations, ICH guide lines, USP methodologies, cGLPs and Saptalis SOPs.
Send your resume to info@saptalis.com
Saptalis is looking to recruit QC Scientists to join the growing Quality group at our facility in Hauppauge, NY.
QC Scientist is responsible for GMP testing of raw materials, in-process, finished product and stability samples for release. In addition, the responsibilities include maintaining laboratory equipment, assisting in investigations and coordinating external testing as needed.
Send your resume to info@saptalis.com
Saptalis is looking to recruit a Validation Associate to join a growing Technical Operations group at our facility in Hauppauge, NY.
Validation Associate is responsible for execution of qualification and validation programs for processing and testing equipment, computer systems, manufacturing processes and cleaning of manufacturing equipment as per FDA regulations and SOPs.
Send your resume to info@saptalis.com