Title: Process Expert Deviation Investigator
Location: Indianapolis, IN – 46268
Duration: 6 Months
Shift: (Mon-Fri 8am - 5pm)
Onsite role Indianapolis
Description:
As a Process Expert you will provide front line support to manufacturing, working with the production team to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions.
Key Responsibilities:
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols,and other documentation as needed.
• Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures(SOP), batch records and white papers.
• Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
• Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.
• Ensure processes are always inspection ready.
• Support process optimization and new technology introduction for continued productivity improvement, as appropriate.
• Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects.
• Provide guidance and support to production team through training and knowledge sharing.
• Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures.
Role Requirements
• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
• 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Strong awareness of quality issues. Compliance investigations experience required.
• Excellent technical writing skills
Desirable Requirements:
• Previous Radio pharma experience a plus
• Prior leadership and/or high cross-functional experience preferred.
Prepares the monthly payroll, conducting the necessary processes for payment of the various components of salary, such as vacation pay, overtime, etc. Is also responsible for payment of legal charges and statutory withholdings, such as employee guarantee fund, social security...
We are looking for Millwork Delivery Drivers for a growing team at a manufacturing and distribution company in Jacksonville . American Builders Supply is Floridas largest independent supplier of lumber, truss, doors and windows. We provide building materials for the...
...SUMMARY The Preschool Teacher will lead the Operation Little Learners program to encourage mother and child bonding so that better relationships are formed between the child and the parent. The program will teach and support parents in educating and nurturing their...
...Project Engineer We are seeking a Project Engineer to support the successful delivery of construction projects from pre-construction... ...equivalent experience). ~14 years of experience in construction, internship or professional. ~ Strong organizational skills with...
About ReadyGo ReadyGo is an experience & travel agency for sales teams - we plan luxury trips that check bucket lists. Our programs center on Presidents Clubs and Sales Kickoffs, where we handle global hotel sourcing & negotiation, bespoke itineraries, transportation...