Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Indianapolis

Description

Summary:
Develops and evaluates quality process and systems standards to ensure compliance with company standards and governmental regulatory requirements. Investigates/troubleshoots validation problems for equipment and/or performance processes. Conducts statistical analyses of testing results and process anomalies; writes, reviews, approves and/or executes documentation for validation procedures and technical reports related to equipment, products and/or processes.
Learning and developing professional expertise. Applies company policy and procedures to resolve a variety of issues. Works on projects of limited to moderate scope. Exercises judgement within defined procedures and practices. Receives general instructions on routine work, detailed instructions on new projects or assignments. Interacts with peers and stakeholders as required to complete tasks.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
What you do:
Provides expertise, guidance and support in the planning, definition, creation, review and documentation of the validation lifecycle activities through deployment of validation policies, procedures and programs to ensure compliance with FDA regulations, Quality Systems Regulations GxP’s, ISPE Good Automated Manufacturing Practices (GAMP) guidelines, and company policies and procedures, safety policies and practices and other applicable internal controls, policies and procedures for all qualification and validation activities.
Understands and translates Validation Program deliverables to ensure validation compliance and completion before the validation records release for the Validation Review Board approval.
Ensure adherence of the validation lifecycle deliverables to the Quality procedures, CAPA, change control, calibration, maintenance and periodic review programs.
Develops, implements and maintains the Validation Program procedures to translate regulatory requirements/guidelines and company policies and procedures.
Prepares, conducts and monitors the Process Development Validation Program Training Plan to assure adherence to the Process Development Validation Program policies and procedures and needs.
Supports periodic reviews for equipment and processes inventory to identify and implement remediation initiatives to comply with standard regulations and GxP’s.
Reports validation program compliance and effectiveness.
Participates in audits (internal, affiliates, government).
Who You Are:
Bachelor’s Degree in Engineering (Mechanical, Chemical) or closely related scientific/technical discipline or equivalent work experience.
5 years experience in medical device or related FDA regulated industry.
2 years experience in writing and execution of validation master plans, user requirement specifications, functional and design specifications, installation and operation qualifications.
Formal training or solid working knowledge of FDA guidelines for validation, Quality Systems Regulations GxP’s (CFR 820, 210, 211 and Part 11), ISPE Good Automated Manufacturing Practices (GAMP) guidelines.
Formal training and/or experience applying Process Risk Assessment, System and Component Classification, FMEA, Control Plans

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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