Supervisor, Formulation and Fill - 2nd shift

Sun Pharmaceutical Industries Ltd•Billerica, MA

1d•Onsite

About The Position

This position is a 2nd shift role, 1:30PM - 10:00PM. Supervise and perform regularly the preparation, formulation and dispensing of pharmaceutical products according to our current Good Manufacturing (cGMPs) and utilize Standard Operating Procedures (SOPs) in a clean room environment. Write and complete investigations, CAPAs, deviations and change controls utilizing root cause analysis tools and reporting software.

Requirements

Bachelor's degree in related field or equivalent experience
6 to 8 years of experience in pharmaceutical manufacturing
Excellent verbal, written and interpersonal communication skills
High level of initiative and self-motivation
Strong computer skills
Attention to detail
Ability to plan, prioritize and organize diversified workload
Team management skills
Record keeping skills
Safe chemical handling techniques
Knowledge of SAP, GMP, GDP, FDA, and OSHA regulations and standards
Minimum 2 – 5 years of supervisory or team lead experience
5 to 7 years of aseptic processing and aseptic area techniques experience
Experience with technical writing, root cause analysis and completing investigations, CAPAs, deviations and change controls

Responsibilities

Supervise and perform the activities of technicians on the second shift in equipment and component preparation operations; dispensing API and excipients; formulation and filling and capping of parenteral drug products.
Oversee the formulation and filling of dermatological drug products.
Schedule weekly plan of floor activities for technicians on second shift.
Author and track to close investigations, CAPAS, deviations and change controls as required.
Troubleshoot and solve moderate to complex problems related to the equipment, processes; existing or new products.
Oversee inventory control in the production area and order supplies as needed for production to assure no delay in the manufacturing plan.
Use systems like SAP, Track Wise, EDMS etc.
Evaluate team performance by conducting midyear and yearly reviews.
Review completed batch records to ensure product is made in accordance with specifications.
Review SOPs and Batch Records, and update through DCRs as needed.
Work under limited supervision and follows clearly described procedures.
Other duties as assigned.