Responsibilities:
- Support product transfer activities, mainly focus on process validation and release product up to commercial release.
- Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
- Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
- Performs system administration and configuration of quality information technology systems.
Qualifications:
- Bachelor’s degree in Engineer or Science
- 3+ years of relevant experience
- Experience with Process Validation, Product Transfer and Process failure mode analysis - First time quality.
- Knowledge on Sterilization
- Knowledge in Final Pack
- 1st shift
Skills Required
- Bachelor's degree in Engineering or Science
- 3+ years of relevant experience
- Experience with Process Validation and Product Transfer
- Experience with Process failure mode analysis / First Time Quality
- Knowledge of sterilization processes
- Knowledge of final packaging (Final Pack)
- Experience validating and administrating quality information technology systems and producing formal validation documentation
- Availability to work 1st shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
