Junior Quality Manager

My client, in the Pharma industry, is looking for a Junior Quality Manager/Process Quality Engineer for a 6 month contract role.

RESPONSIBILITIES

* Understanding of software validation requirements with respect to IGM (Information Governance & Management), Information security, Data Integrity, GAMP guidelines and the requirements of 21 CFR Part 11. Understanding of GXP.

* Understanding of documentation change control, review, approval and archiving requirements and the ability to ensure procedures are efficiently and consistency applied.

* Ensure Business Processes & Validation Master Plans are established and updated where necessary.

* Approve and compile where appropriate CSV protocols and reports.

* Develop templates and write/edit validation documentation as required.

* Manage the IQ,OQusing technical expertise, skills, knowledge and experience as required.

BACKGROUND AND EXPERIENCE

- 3-5+ years of working experience in IT Quality CSV operations or compliance
- Experience or knowledge of GXP
- Experience in application management
- Experience in AGILE methodologies
- Experience in IT Quality and Test Management tools
- 2-3 years test and deviation management
- Risk management background with experience in risk management related roles
- Knowledge of general IT, project management and compliance domains.
- Good understanding of business processes and objectives
- Good written and verbal communication and presentation skills
- Preferably expert knowledge of one or more information governance & management disciplines
- High level of customer focus with proven problem solving skills
- Detailed knowledge and understanding of CSV, 21 CFR Part 11 and GAMP
- Excellent technical writing ability
- Experience in working in a multinational heavily matrixed organization
- Remote working with international projects/teams

If this is something you are interested in please call: Rachel or email: (see below)