Sun Pharmaceutical Industries-posted about 2 months ago
Full-time • Entry Level
Chattanooga, TN
5,001-10,000 employees
Chemical Manufacturing

The Validation Chemist is responsible for developing and executing validation protocols for equipment, facilities, processes, and cleaning procedures to ensure compliance with cGMP standards. This role involves planning and scheduling validation activities, conducting studies, and preparing comprehensive reports. The chemist supports quality assurance by reviewing batch records, monitoring QMS records, and ensuring audit readiness. They serve as a key resource for quality-related information across departments and contribute to continuous improvement initiatives by evaluating and enhancing SOPs and procedures. Additional responsibilities include assisting with audits, maintaining QC method training programs, completing Annual Product Quality Reviews (APQRs), and supporting compliance.

  • Develops validation protocols for equipment, facilities, processes, and cleaning procedures.
  • Plans and schedules validation activities.
  • Performs validation studies per schedule and written protocols.
  • Accurately accumulates, documents, and communicates data.
  • Prepares and submits validation final reports.
  • Audit and ensure the site is always audit ready by ensuring compliance to cGMP, SReview and approve batch records as needed to ensure quality compliance.
  • Monitor and ensure on-time closures of all QMS records daily.
  • Review and approve orders as they ship to ensure quality compliance.
  • Available to be the first source of quality information needed by all CCI departments.
  • Recognize, recommend, evaluate, and implements steps to improve procedures, SOP's, and products.
  • Complete APQR's as needed
  • Monitor and update QC method training program and method table of contents as needed.
  • Assist in all customer, corporate, and regulatory audits as needed.
  • Other activities as instructed from time to time.
  • B.S. degree in Chemistry or related field.
  • 1-2 years of experience in a GMP environment preferred but not required.
  • Proficient in the use of Microsoft suite/365.
  • Must work effectively both as an individual and as a team member.
  • medical
  • dental
  • vision coverage
  • life insurance
  • disability insurance
  • 401(k) savings plan
  • flexible spending accounts
  • employee assistance program
  • vacation time
  • sick time
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