QA (QMS) Specialist Lead - Pilot Plant

CIPLA LTD•Fall River, MA

61d•Onsite

About The Position

The purpose of the Quality Assurance Production Lead (QMS) is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs) and to [provide guidance to Quality Assurance associates. The Quality Assurance Production Lead (QMS) is an individual contributor role and a member of the InvaGen Pharmaceuticals Quality team. The position reports to the Quality Assurance Manager.

Requirements

Bachelor's degree, Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university.
Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.
Understanding of machines used in pharmaceutical manufacturing.
Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
Effective interpersonal relationship skills and the ability to work in a team environment.
Capable of conducting troubleshooting, investigations and root cause identification and analysis.
Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
Must be proficient in computer skills and software applications such as Microsoft Office tools.
Proficiently speak English as a first or second language.
Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.
Knowledge of good manufacturing practices and good documentation practices preferred.
Ability to read, write and communicate effectively.
Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
Excellent organizational skills with the ability to focus on details.
Must be willing to work in a pharmaceutical manufacturing setting.
Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
Must be willing to work some weekends based on business needs as required by management.

Nice To Haves

Master's Degree, Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.
Experience using SAP business system and applications is a plus.
Experience in Inhalation products (MDI) is a plus.

Responsibilities

Review of batch manufacturing/packaging records.
Release of raw materials, packaging materials and finished products through approval of respective COA.
Review of engineering records such as temperature and humidity data calibrations, preventive maintenance records, pest control records and contractor related functions.
Review and approval of manufacturing/engineering non-conformance.
Review and approval of manufacturing /engineering change controls, deviation investigations and CAPAs.
Reviews and approves manufacturing/engineering qualification documents.
Provides daily/weekly updates to the shop floor and management regarding quality highlights/concerns.
Creates lessons learned for training as communication mechanism to shop floor personnel.
Leads manufacturing quality associates on daily activities including the assignment of weekly work schedules.
Performs training and onboarding of QA associates to ensure they are qualified prior to beginning their daily functions.
Acts as quality lead for all shop floor questions/concerns.
Acts as back up for shop floor QA associates.
Other duties as assigned by department head.