Compliance Engineer na AVEVA DRUG DELIVERY SYSTEMS INC

Description

Job Responsibilities

• Initiates, reviews and completes Investigations for engineering deviations, investigations, CAPAs, and change controls, working closely with Engineering SMEs.
• Becomes Subject matter expert for engineering relevant SOP’s and forms.
• Reviews and analyzes documents to support completion of the investigation process.
• Serves as an investigation team leader to assess impact on product quality, calibration, facility and utilities compliance and validation status.
• Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
• Ability to summarize the results of an Investigation in writing.
• Works together with multiple departments to troubleshoot the production processes and identify process improvement opportunities. 
• Provides training and mentoring to colleagues performing investigations.
• Writes/revises SOPs relevant to the Engineering department.
• Working with the Production and Quality teams, assess events when they arise to determine the ability to resume production.
• Performs assessments / approvals of change controls related to production activities.
• Attends meetings to provide updates as well as take away any actions required to be communicated.
• Ensures compliance with all Company policies and procedures including safety rules and regulations.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned.

Qualifications

Job Requirements

• Education

A bachelor’s degree in engineering or Life Sciences from an accredited college or university.

• Knowledge, Skills and Abilities

Analyzing and troubleshooting problems, identifying root causes and recommending and implementing effective methods, procedures, systems and/or techniques.

Proficiency with MS Office and other software used in the creation, review and approval of GMP documentation.

Ability to prepare / edit all types of pharmaceutical documentation (batch records, SOPs, protocols, summary reports, etc.).

Ability to create reports.

Sound knowledge of the FDA pharmaceutical regulations. Thorough understanding of GMPs, specifically those relating to good documentation practices.

• Experience

Minimum of 3-5 years of experience or a master’s degree and 1-2 years of experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.