Description
Duties:Develop an implementation strategy to update/revise design history files for marketed combination products with gaps and including a sustainable going forward process
Work with project teams, vendors and suppliers and perform risk management to facilitate gap analysis
Work with project teams and vendors and suppliers in developing combination product design control documentation
Responsible for generation and storage of all design control documentation for assigned projects
Provide support in establishment of documents to ensure effective device change management including revision of current procedures as identified ensuring that quality and regulatory requirements are met
SKILLS:
Qualifications:
Degree or equivalent in a scientific discipline.
Over 5 years GMP experience working with devices and combination products.
Experience in GMP role with some combination of applied quality system experience/engineering/regulatory experience.
Experience in Device Design Controls, is a must. Medical device software experiences is desirable.
In depth knowledge of cGMP specifically 21 CFR 820 and the principles and concepts of relevant quality processes and systems.
Previous experience with the development and/or documentation of drug delivery devices.
Strong communication skills
Comfortable working and making risk-based decisions when there is some ambiguity
Develop good working relationships with diverse teams
Dedicated to problem solving and meeting the expectations of internal and external customers.
Ability to lead and deliver in a Matrix environment is desirable
Prior experience in management of external contractors is desirable
Prior experience of SOP interpretation and performing gap analysis
Understanding of device quality system principles specifically design controls(as well as cGMPs) & ability translate into operational use
Ability to converse with varying management levels and with various skills/knowledge/abilities across different disciplines
Prior QA/technical experience in devices is a must
Some knowledge of regulations in medical device software application tools is desirable
Proficient in Microsoft Word