Stability Coordinator at Cranbury

Job Description

SUN Pharma USA is a major global pharmaceutical company with annual sales of over US $2.09 B and a market cap of US $5.2 B.  SUN Pharma USA is ranked among the top pharmaceutical companies in the world and is a leader in the niche areas of Psychiatry, Neurology, Cardiology, Diabetes, and GI.  The 250,000 sq. ft. site in Cranbury, NJ is a strategic manufacturing site for Sun Pharma USA, US based operations.

Job Summary:

Under the direction of Laboratory Management, this position administers the QC Stability Study program, writes investigations, creates and reviews stability study summaries, and assesses overall compliance of the stability program.

Essential Job Functions:

 

• Authors stability study protocols, reports and Standard Operating Procedures (SOPs) related to the QC stability program.

 

• Plans, schedules, coordinates, and documents the storage, pulling and testing of stability samples for developmental and commercial studies.

 

• Initiates stability studies and ensures that samples are properly stored at the specified conditions.

 

• Ensures that stability studies start on schedule, to comply with regulatory requirements for the annual evaluation of commercial products, as well as for supporting process changes and products under development.

 

• Maintains complete and accurate records and logbooks for the stability chambers (e.g., temperature/humidity charts and logs, maintenance, calibration, repair, and IQ/OQ/PQ protocols and reports) to confirm that environmental conditions comply with established specifications.

 

• Writes investigations related to stability program and stability chambers.

 

• Creates and reviews stability study summary spreadsheets

 

• Coordinates with technical staff and external contractors to ensure that calibration and maintenance schedules are completed according to plan.

 

• Manages multiple assignments simultaneously while working independently.

 

• Assesses the overall compliance of the stability program with established protocols, SOPs, company policies, and   applicable regulations.

 

• Collaborates with colleagues and external partners to achieve primary Department goals.

 

• Ensures compliance with cGMP’s, DEA regulations and site operating procedures under the direction of Management.

 

Works in coordination with project plans and goals as assigned by Management

Job Requirements

 

• A BS or MS in a scientific field with at least 3 years experience in the Pharmaceutical Industry.

 

• Excellent computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint and Access).

 

• Strong written and oral communication skills

 

• Must be able to work independently.

 

• Must have an understanding of USP requirements, and FDA and DEA regulations.

 

• Must be familiar with proper cGMP practices for analytical laboratories.

Physical Requirements:

May require lifting of up to 30 lbs.
Country: USA, State: New Jersey, City: Cranbury, Company: Sun Pharma USA.