Roberto Caiffa Email & Phone Number

Athlone, Contea Di Roscommon, Irlanda

- Supervising & assisting Group Leaders, Scientists & Technologists in Laboratory Operations with tasks such as scheduling, managing resources & supporting with technical/compliance related issues.- Planning, directing & implementing improvements in systems/processes/procedures to increase efficiency, productivity & quality in the laboratory.- Assisting the division Director in strategic planning, business development & expansion initiatives by providing mid-range resources utilization predictions for the assigned departments.- Interacting with clients and business development on requests for proposals & project definitions.- Preparing, reviewing & approving bids & proposals, SOW and pricing. Negotiating with clients on timelines & pricing- Managing/directing work responsibilities of Group Leaders as well as prioritizing talks & resources- Preparing & updating revenue projection reports, reviewing systems and timesheets reports for revenue recognition and billing.- Evaluating resource utilization reports and projects profitability- Assisting upper management in strategic planning, budgeting, new capabilities development & other responsibilities

Athlone

Providing oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc. Managing the work activities of group and associate group leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. Ensures the compliance of work performed within the laboratory as well as working with manager to meet the financial goals of the organization.Key Functions:- Reviewing and approving study protocols, project status reports, final study reports and other project related technical documents. Designing experimental studies and participating in technical troubleshooting- Allocating, scheduling and managing laboratory resources for group's project activities and updating project status and revenue projections. Reviewing timesheet reports for billing accuracy- Reviewing data for technical quality and compliance to protocols, methods and SOPs. Approving laboratory investigations, deviations, QA facility and data audits. Leading client and FDA audits- Responding to clients questions and needs; leading client technical meetings. Providing recommendations to clients on analytical and compliance issues- Preparing and approving proposals/contracts, project definition and pricing. Participating in project definition and negotiations with client on timelines and budget- Identifying and supporting business opportunities at conferences, workshops, within the community, through client interaction, etc. Participating in technical sales and marketing; preparing technical marketing materials. - Participating in bi-annual SOP review & change (Ownership of changes needed to comply with SOPs)Regularly communicating to staff quality related issues and items for staff development and implements quality improvements

Athlone

Providing management coordination of resources and work schedules for laboratory activities. Ensuring that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed.• Providing management and direction to laboratory staff and resources for project activities and needs.• Overseeing daily operations and assisting in preparation and implementation of company policies, quality systems and training programs. • Ensuring the projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed.• Responding to client questions and needs, coordinating client communication and recording meeting minutes.• Directly supervising administrative support and/or technical staff• Planning and monitoring the progress and quality of projects by utilizing the financial and quality management tools available at PPD

Athlone

Overseeing daily operations and assisting in preparation and implementation of company policies, quality systems and training programs.• Ensuring that laboratory staff continues to be developed to keep pace with department goals and growth. • Directing lab work in accordance with client protocols, methods and requirements.• Designing experimental study and participating in technical troubleshooting. Organizing, scheduling and supervising laboratory resources for group's project activities and updating project status.• Assisting group leaders in their responsibilities.• Assisting in preparation and implementation of SOPs and company operational policies. • Ensuring adherence to SOPs, safety standards and company policies.

Athlone, Ireland

Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other special technologies such as extractable/leachable studies. Performs troubleshooting on multiple analytical instrumentation (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), calculates and interprets data, and records data in adherence with SOPs and any additional requirements specific to the lab and/or client. Routinely acts as the technical project leader for multiple projects, interacts with clients on a weekly basis (or as needed) to provide updates, reviews and evaluates data, writes reports and protocols.•Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.•Prepares and reviews study protocols, project status reports, final study reportsand other project-related technical documents.•Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs.•Communicates data and technical issues to clients on a weekly basis (or asneeded).•Provides technical guidance and training to staff.•Leads analytical (procedural and instrumental) troubleshooting sessions.•Assists in preparation and implementation of SOPs and quality systems.

Dublino

Responsible for the stability setup of commercial products as per NDA post-approval commitments.Manage and supervise the weekly stability sample pulls based on schedule or as needed by the department.Coordinate and manage stability study team.Perform inventory of all stability chambers and update inventory as necessary.Statistical data trend/evaluation of stability study results via LIMS.Updating stability protocols within the database.Organize and maintain stability chambers in accordance with SOP and GMP requirements, ensuring accuracy and reconciliation with LIMS database entries.Liaison between QC and QA for the release of samples.Liaison with EHS for sample destruction post-stability.Responsible for managing daily administrative activities for multiple managers.Prepares expense reports and daily attendance logs.

Capua

Managing the Chemical Quality Control Laboratory, coordinating the work of the analysts.Managing resources, complying with budgets and cGMP, GLP and Health & Safety guidelines.Identifying the specific training needs of quality control employees.Purchasing laboratory consumables and equipment.Defining and writing standard operating procedures (SOPs).Drawing up specific sampling procedures for finished products and raw materials.Checking the results of analyses in accordance with workplans, specifications, control methods, and current Health & Safety and cGMP/GLP/ICH/FDA standards.Managing the validation of chemical cleaning processes.Managing the analytical method validation in compliance to ICH guidelines; verification of compendia methods as per global procedures.Providing the chemical and physical analytical data, test procedures and validations required for drug product registration and regulatory variations.Providing expert QC support in the validation of drug product manufacturing processes.Ensuring all documentation (stability protocols, reports, test methods, etc.) are prepared and approved as per site and global SOPs, and as per cGMP, EU and FDA guidelines.Managing the efficiency of equipment, ensuring timely maintenance, calibration, initial and periodic qualification, and identifying potential cGMP/GLP, Health & Safety non-compliances.Investigating OOS results to find an assignable root cause and implement timely CAPAs.Managing the Stability Testing Programme.Performing laboratory investigations for out of specification (OOS) and out of trend (OOT).Performing analytical testing for process failures and/or complaints from the market.

Capua

Carrying out chemical analyses of raw materials (active ingredients, excipients), pharmaceutical packaging materials, semi-finished and finished dosage forms.Laboratory testing of starting materials to BP, EP and USP specification.Carrying out stability studies (commercial stability, ICH, stress testing, in-use stability).Carrying out analytical validations and process validations.Developing and optimising new analytical methods and operating procedures.

Napoli, Italia

Carrying out chemical and physical analyses of drinking water, industrial waste and compost.Probing samples of soil and analysing contaminated soils at high risk of toxicity.

Napoli, Italia

Carrying out chemical and organoleptic testing of grapes for wine production, musts, and wines.

Degree In "Quality Assurance In The Pharmaceutical Industry", Università Degli Studi Di Napoli "Federico Ii", 110/110 Cum Laude

Diploma In "Experienced Technical Development And Environmental Monitoring", I.T.I.S. Di Pozzuoli

Secondary School Diploma In "Technical Industrial Chemistry", I.T.I.S. Di Pozzuoli, 50/60