Gurprit Birk Email & Phone Number

London, London, GB

Responsible for managing all activities associated with complex Injectable development to support ANDA and 505(b)(2) regulatory submissions thru to commercial launch. Main interface with external global manufacturing / testing / Clinical trial sitesResponsible for leading, directing and overseeing all planning, procurement and vendor management for.

Pine Brook, New Jersey, US

Reporting to the Senior Vice President, R&D was responsible for managing the centralizedProject Management Office (PMO) that served all the business units and departments at Alvogen US.Supported both generics and 505(b)(2) brand R&D at all internal and external global sites,regulatory submissions, FDA approval, process validation, S&OP, and commercial.

Tel-Aviv, IL

• Program director working in Teva’s Global Network & Product Strategy group.
• Overall accountability for on time delivery of product transfers
• Establishes and aligns tactical program execution plan (timelines, resource, budget, costs) with key stakeholders
• Establishes project structure and processes and works with project managers to ensure projects are executed as per plan.
• Communicates project status and timelines to key stakeholders and snr mgmt.
• Liaises with R&D, Quality, RA and operations to identify timeline, quality or cost risks and execute recovery strategies where required

Dublin, IE

• Provide leadership for the successful execution of product transfer strategies.
• Clearly communicating strategies and any changes in strategies as necessary.
• Leading the planning and execution by engaging multiple functional areas, sites and internal / external stakeholders to drive strategies thru to completion based on a common goal.
• Hands on Project management, also provided project management mentoring to project managers and other functional groups within the organization.
• Product launches including agreement on launch strategies and subsequent transfer plans
• Establishing performance metrics to measure progress / success and ensuring these are monitored and reported to Snr. Management.

Dublin, IE

Managed the start up of an off shore manufacturing facility which resulted in the granting of FDA approval within 2 yearsSet up systems and policies to comply with FDA requirements / regulationsCompleted the validation / revalidation of equipment, utilities and facilities to comply with cGMP requirementsSuccessfully transferred the manufacturing and.

• Project Manager responsible for managing high profile organization level projects. Managing a project portfolio to ensure the successful launch of new products on time which involves managing competing timelines and.
• Company wide initiative to obtain "Operational Excellence" throughout the Supply chain which involved 6 manufacturing plants as a precursor to a Global SAP implementation. Developed best practices and metrics.
• Successfully implemented a large scale computer system (Trackwise) across 5 Watson sites. Working closely with a cross functional team from IT, QA, Validation and Business Units.As a member of the Technical operations.
• Providing Technical Operations Management with project management support as needed.
• Leading focus area projects within the organization, for example; RFID Implementation and the development of a Recognition and Rewards program.

Assigned to Watson Laboratories, IncProject manager for the successful implementation and validation of FDA compliant software for the reporting of Adverse Drug Reactions (Argus), project completed on time and within budget.Responsible for all project planning, tracking and reporting to ensure successful implementation. Duties included liaising closely.

Responsible for managing the activities of 15 IQ/OQ/Computer System Validation Engineers, carrying out retrospective/prospective validation of computer systems, equipment, plant and utilities to ensure compliance with Company and GAMP requirements. Duties included project planning and ensuring tight deadlines are met by managing the resources available..

• Project Manager / leader involved in a number of projects in the U.K and Europe. Responsible for supervision of client/contractors/validation engineers during validation activities. Clients included;
• Swiss Serum Institute, Switzerland
• Boehringer Ingelheim, UK
• Pfizer, UK
• Bilim, Turkey
• Cordis, Switzerland

Reporting directly to the Quality Assurance Manager, responsible for all validation work carried out on site. Creation and updating of Validation Master Plans for a number of different projects. Responsible for co-coordinating and reviewing all external contractors involved in validation areas such as clean rooms, calibration and sterilization.Team leader.

Responsible for all validation studies, involving the writing of accurate protocols and reports and ensuring all studies were completed. Responsible for the validation of equipment and services used in the manufacture of products.

Responsible for co-coordinating and participating in the (re)validation and (re)calibration of equipment, plant, and processes in the Research and development department in a manner that satisfied GMP/GLP, company standards and regulatory authority departments. Preparation and review of SOP’s, maintenance/calibration procedures, validation protocols/.