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.
...Medical Center in Corona, CA is assisting a local, well-established, and highly successful GI group in recruiting a BC/BE Gastroenterologist to join the practice. Join two GI physicians and supporting APPs in a busy, contemporary offi... Universal Health Services (UHS)
...Full-time Description Athenix Solutions Group is looking for Embedded Software Developers for low-level development working directly with hardware resources Do you have skills and experience in some of the following areas? DevSecOps using modern tools...
...day Manage and organize footage Cut together rough assembly edits for multiple videos in a day Be organized and process-... ...music to timelines and have basic knowledge of recording scratch audio when necessary. Basic understanding of applying LUTS and color...
...Job Description Job Description Job Summary ~ Cuts, styles and colors hair. General Accountabilities ~ Washes, shampoos, conditions and rinses hair. ~ Evaluates clients' hair and physical characteristics to recommend appropriate hair style. ~ Cuts...
EMPLOYMENT OPPORTUNITY CHIEF ADMINISTRATIVE OFFICER The City of Port Allen is now accepting applications for the position of Chief Administrative Officer . Applicants must possess the following qualifications: 1. B.A. or B.S. degree from accredited university....