Bhavna Patel Email & Phone Number

Lincoln Park, Nj, Us

Lincoln Park, Nj, Us

IT Quality and Compliance oversight and guidance for all sites and business units under and adjacent to the global R&D organization (which includes Clinical, PhV, Regulatory Affairs, Digital Health, R&D Labs, Medical Affairs, Patient Services/Technologies, Commercial business units). Guidance provided is ensured to be operationally feasible while in alignment with Teva internal policies and applicable regulatory guidelines (eg. applicable GxP regulation, 21 CFR Part 11, EudraLex Vol 4 Annex 11, HIPAA, GDPR) surrounding Data Integrity, Security and Privacy principles.

• Lead Computer systems validation for several enterprise-wide software implementations using a risk-based approach to ensure that the necessary amount of data and verification documentation is being collected to not only confirm that system meets it’s intended use but allows any gaps/issues to be caught and addressed. Activities in support of application development and release for use in a GxP environment included, but was not limited to, the gathering of user / business requirements and the drafting and review of SDLC artifacts such as test and acceptance scripts, system SOP / training development.

Ensured workplace safety and business processes met regulations and guidelines established by various local, state and federal governmental agencies (eg. FDA, EPA, NJDEP, NRC, OLAW). Site budgeting and resource management.

Edgewater, Nj

Managed multiple elements of a new venture launch operation, including the creation and oversight of marketing strategies, protocol and product development and staff management.