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Summary
The centralized TMF organization is responsible for the completeness and accuracy of the Trial Master File for all BMS-sponsored studies. The group will deliver technical expertise in the Trial Master File (paper TMF & electronic TMF) management and will provide support for the book of work for all BMS-sponsored clinical trials throughout the lifecycle of the trial. The group will support inspection readiness goals in compliance with ICH/GCP Guidelines, regulatory requirements and BMS internal policies.
Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all BMS-sponsored studies, working with the study teams and Protocol Managers. Subject Matter Expert for TMF/eTMF, spans across all therapeutic areas and research phases, collaborates with cross-functional, global clinical research studies throughout the lifecycle of the trials.
1. Performs the assigned activities related to the equipment set-ups, changeovers equipment cleaning, and line clearance to achieve an efficient operation of the different processes and products yield maximizing.
Operates and understands the preparation, formulation and filling equipment functions and basic troubleshooting activities
Cleans, sanitize, and sterilize manufacturing area rooms and equipments.
Runs autoclaves to sterilize equipment to be used in the manufacturing process.
Performs CIP and SIP (Cleaning in Place and Sterilization in Place) of the tanks.
Performs integrity test of all filters used in the process before and after each use.
Receives, handle, verifies and weigh excipients and drug substance and or active ingredient to be used in the formulation process.
Executes the product formulation as per Batch record and Procedure instructions; this includes pH measurements and adjustments, yield calculations, and volume adjustment.
Performs sampling of bulk solutions as per batch record requirements.
Interacts with computer controlled equipment and processes.
Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.
Verifies calibration status of critical instruments before process operation.
Operates in an efficient manner of the manufacturing processes to maximize product yield of products.
Maintains housekeeping within controls and aseptic environments, according to procedures.
Performs systems integrity test such as isolators, ultra filtration skid, distribution systems, filters and gloves as required. Complete production documentation legible, error free and on time following good documentation practices.
2. Ensures the completeness and compliance of all required documentation during the manufacturing process.
Maintains inventory and request all necessary components and operating materials.
Receives, verifies all production records and transaction documents to be error free and in compliance with established procedures, including computer generated transactions.
Completes production documentation legible, error free and on time following good documentation practices.
Audits batch records and documentation, as required.
Assures that the Compounding equipment is in good working condition, clean, labeled, and calibrated and/or qualified according to applicable SOP’s before performing the formulation process.
Revises and improves procedures and develops new SOPs based on observations and experiences.
3. Provides assistance and supports to manufacturing related activities
Initiates, participates, and assists in resolution of quality investigations.
Assists in “on the job training” for new employees.
Participates in special projects and during audits and regulatory inspections as required.
Participates and assists in area validation and qualification activities.
Supports Environmental Monitoring Program by assuring samples collection on established timeframe.
Supports Annual Requalification Program by assuring plan execution on established timeframe.
Assists manufacturing activities in other areas within operations as required.
Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to supervision, as requested by supervisor.
4. Performs GMP Safety and Environmental regulatory tasks required in the manufacturing area.
Maintains housekeeping within controls and aseptic environments, according to procedures.
Handles Hazardous and Non hazardous waste according to EHS procedures.
Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
Knowledge/Education:
High school diploma with, two (2) years of experience in Parenteral Manufacturing Process or three (3) years of experience in pharmaceutical manufacturing process.
Knowledge of preparation, formulation and filling processes.
Basic writing skills when completing area documentation.
Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes.
Ability to work with minimum supervision.
Ability to provide job training, theoretical and or On the Job, for new employees following the Parenteral Operations Department Qualification Curriculum.
Knowledge of all critical process parameters and their impact in product quality.
Knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization and isolators technology. .
Understanding of Process Equipment set-up and able to perform it repeatedly and according to SOPs.
Ability to apply critical thinking to resolve complex issues.
Excellent leadership characteristics, accountability and commitment.
Team player and collaborating skills.
Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
Skill in performing detailed tasks and documenting information.
Ability to enter data into a computer and perform complex process transactions.
Skill in accurate visual inspection (e.g. product and components defects)
Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
Skill in basic mathematical applications.
Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
Strong organizational skills
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
