...Provides compliance leadership to the manufacturing site.
Provides direct interface with FDA and other regulatory agencies. Develops and communicates tone for successful, cooperative inspection. Directs any and all resources necessary to participate in audit....
...performing calibrations to Bioreactors, Utilities, Formulation, Aseptic Areas.
Experience in Blue Mountain (RAM), Calman, or Procal Software is highly preferred.
Must possess experience in:
Temperature
Technologies
Pressure
Humidity
Flow
Mass
PH...
...highly technical and regulated environment. This position requires developing and implementing changes that will improve equipment... ...manufacturing costs, maintaining a constant product turnover. Develop and modify procedures as needed to support the manufacturing operation...
...decision-making process to ensure that root cause analysis is performed and resulting corrective/preventive actions are systematically developed to ensure recurrences prevented. Ensures adherence to investigation timeframes and milestones, regulatory expectations and AbbVie...
...Assurance Audits. Conduct program assessments to ensure regulatory and internal compliance and consistency of program implementation.
Develop best-in-class EHS audit practices, framework, approach, policies, and programs to enhance EHS compliance by working collaboratively...
...Alerts management when problems are identified and make recommendations for improvements.
~ Must be a team player committed to developing and working in a quality environment.
~ Complies with MENTOR’s administrative requirements timely and consistently in areas such...
...and identify ways to improve communication efforts.
Excellent computer skills including some experience in design and marketing software.
Availability to travel to the Eastern and Central area of Puerto Rico.
Must be fully bilingual.
Education: Bachelor’s...
...objetivos y estándares de la empresa, mediante el manejo óptimo de los todos los recursos de la organización (personal, hardware y software). Adicional deberá asegurar la calidad del servicio en cada cliente atendido, asegurar la experiencia positiva y el seguimiento...
...accuracy, with the ability to organize and maintain large volumes of documents.
~Proficiency in document management systems and software (e.g., SharePoint, Documentum).
~Excellent communication and interpersonal skills, with the ability to work effectively with cross...
...Source pet food ingredient and other raw materials for products, including researching, evaluating, and negotiating with vendors. Develop and maintain relationships with vendors. Manage the development and implementation of processes to ensure compliance to pet product...
...verbal instructions by inspecting the work site to determine the materials, equipment, tool requirements, and methods to be used, developing a plan or lay out for the project or following a blueprint, sketch or schematic, assembling, fabricating or building and...
...coordination.
Mechanical projects.
All project stages: developing documentation to request a quote, generating reports and leading... ...tools.
Coordinate system completion and turnover.
Develop a working knowledge of applicable codes and standards.
Requisition...
...Sense of urgency and analytical thinking
Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP
Solid ability for analyzing data detecting deviations, inconsistencies and interpret...
Bachelor's Degree in Engineering - 5 years experience
Duties:
1 - Overall Project Management Activities
2 - Develop Schedule
3 - Monitor Project Progress and Set Deadlines
4 - On Hand experience in problem solving (Manufacturing Areas, Facilities, Equipment, Utilities...
...budget established for the branch, as well as attracting new business opportunities; explore new ideas and manage existing ones, and develop established strategies to achieve the financial goals of the company. The position implies collaboration with other departments of...
...company standards and regulatory agencies.
~ Maintains statistics, develops reports and files official reports with regulatory agencies.... ...incident investigations program to determine rood cause and develop action plan to avoid recurrence and follows-up to ensure improvements...
...procedures, packaging machinery specifications, performs line trials and troubleshooting, works with packaging machinery vendors, etc.
Develop reviews and approve packaging Bills of Materials, labels, and component specifications.
Coordinate packaging validation and line...
...Facilitate bi-weekly program status update meetings to review progress, address issues, and align strategies with key stakeholders.
# Develop and report key performance indicators (KPIs) to monitor the effectiveness and efficiency of laboratory asset management processes....
...place to meet the project’s goals and timeline.
~Continuously reviews plan execution against target. Anticipate problems and risks, develops alternatives, and ensures key contributors are fully apprised of changes and developments.
~Escalate any conflict or potential...
...preventive, and corrective maintenance in the most effective and efficient way.
Review and approve/disapprove incoming work requests.
Develop and report work backlog reports.
Develop the detail work scope and setup forecasts for resource allocation to ensure calibration...
...company standards and regulatory agencies.
#Maintains statistics, develops reports and files official reports with regulatory agencies.... ...incident investigations program to determine rood cause and develop action plan to avoid recurrence and follows-up to ensure improvements...
...Provides support to the area QA Leader during the budget preparation activities.
~Evaluates department performance indicators and develop the appropriate corrective actions if needed
~Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA...