Responsabilites:
Provides to the site knowledge and experience in Quality Systems.
Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
Reviews processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and MMD IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols etc.
Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
Experience:
3 - 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
Experience in SDLC (Software Development Lifecycle) and experience of working on computerised systems preferred.
Experience in reviewing and approving GMP documentation from a Quality point of view Knowledge of change control process and approval from a quality perspective desired.
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to work and succeed within teams as well as leading small project teams.
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.
