...conformance with cGMP’s plant procedures, corporate policies, and applicable regulations (FDA, ENEA, DEA, etc.)
Prioritizes projects and... ...data integrity requirements, following sites procedures.
Develop data integrity assessments and data mappings for new systems...
...and procedures to ensure compliance with applicable local, federal regulations and company... ...regulatory agencies.
~ Maintains statistics, develops reports and files official reports with... ...program to determine rood cause and develop action plan to avoid recurrence and...
...role will be responsible for developing, planning, and executing EHS... ...management.
Develop and implement new environmental... ...ongoing support in their roles. Applicants can request a reasonable workplace... ...records, pursuant to applicable laws in your area.
Any data...
...address issues, and align strategies with key stakeholders.
# Develop and report key performance indicators (KPIs) to monitor the... ...Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to...
...responsibility for taking action, making final decisions and developing recommendations. Limiting factors might include existing policies... ...and other regulatory standards
• Knowledge of computers applications (Microsoft Word, Excel, Power Point)
• Excellent leadership...
....
Review and approve/disapprove incoming work requests.
Develop and report work backlog reports.
Develop the detail work scope... ...Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race...
...and procedures to ensure compliance with applicable local, federal regulations and company... ...regulatory agencies.
#Maintains statistics, develops reports and files official reports with... ...program to determine rood cause and develop action plan to avoid recurrence and follows...
...a liaison between Site and Corporate Headquarters groups for applicable projects.
~Establishes and leads cross functional project teams... ...plan execution against target. Anticipate problems and risks, develops alternatives, and ensures key contributors are fully apprised...
...******:Bachelor Degree in Science (Biology, Chemistry, Engineering or related EH&S field)Five (5) years of experience leading Environmental areas in the Pharmaceutical, or Chemical industry.Fully cognizant of applicable Federal and Commonwealth rules and regulations...
...through quarterly, monthly, weekly, or daily operations audits, as applicable.
#Ensures compliance of all procedures (SOP’s) to avoid... ...activities.
#Evaluates department performance indicators and develop the appropriate corrective actions if needed.
#Assists management...
...discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,...
...equipment failure and frequency.
~Improves equipment reliability through FMEA, root cause analysis, and 8D problem solving methods.
~Develop maintenance job plans, troubleshooting guidelines and equipment care manuals for Solid Oral Dosage Equipment. (i.e. Blender,...
...and or weekends if necessary.
Experience in:
Equipment Validation Expertise (URS, DQs, Validation Master Plan PQ)
Maximo application user
Infinity application user
The Personality Part:
~ If you have a commitment to serving customers with high-quality...
...with global teams and in a heavily matrixed environment.Proven application in leveraging business acumen and external insights to... ...qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role...
...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...
...alignment with manufacturing processes and compliance standards.
Collaborate with cross-functional teams to define system requirements, develop user specifications, and oversee system integration activities.
Customize and configure MES and EBR software modules to meet...
...equipment qualification documents development, execution and report as well as laboratory test method creation and configuration in the applicable instrument software.
Regulations (Risk Assessment, Data Mapping etc.), EU regulations and the ability to interpret and apply...
...Specifications (URS), Design Specifications(DQ), Risk Assessment(RA), Data Mapping/Data Flow/data Integrity, Audit Trail Review Applicability, Traceability Matrix, Installation, Operational and Performance Qualification, Validation Plan and Reports, DCS, QBASM and QBAS...
...methodology – come be part of the solution with us.
Clean Harbors is an equal opportunity employer. We do not discriminate against applicants due to race, ancestry, color, sexual orientation, gender identity, national origin, religion, age, physical or mental disability,...
...Must be fully bilingual (English / Spanish) with excellent oral skills.
~Must be proficient using MS Windows and Microsoft Office applications.
~Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance....
...operations / qualifications, data loggers and Kaye validator systems
~Good skills writing general documentation in English and using MS Office applications.
~Bilingual (both English/Spanish)
~Available to work extended hours, possibility of weekends and holidays....
...Must be fully bilingual (English / Spanish) with excellent oral skills.
~Must be proficient using MS Windows and Microsoft Office applications.
~Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance....
...Must be fully bilingual (English / Spanish) with excellent oral skills.
~Must be proficient using MS Windows and Microsoft Office applications.
~Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance....
...EPA and other regulatory standards
~Knowledge of computers applications (Microsoft Word, Excel, Power Point)
~Excellent interpersonal... ...reoccurrence.
~Reviews and provides input to regulatory submissions applicable to area of responsibility
~Leads QE’s and CAPA’s trend...
...administration and maintenance of assigned OT systems as per applicable departmental procedures.
Responsibilities:
Acts as Subject... ...OT Systems lifecycle including validation activities by developing and executing qualification protocols plus associated documentation...
...technical expert who will independently investigate, identify, develop and optimize new methods/ techniques to address critical... ...mostly through lab and/or pilot plant based activities where applicable.
Qualifications
Qualifications
BS or equivalent education...
...materials, equipment, tool requirements, and methods to be used, developing a plan or lay out for the project or following a blueprint,... ...Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to...
...appreciation. Ensure adherence to quality expectations and standards. Develop and maintain positive working relationships with others;... ...and veteran status, or any other basis covered under applicable law.
At more than 100 award-winning properties worldwide, The...
...co-workers using clear, appropriate and professional language. Develop and maintain positive working relationships with others;... ...disability and veteran status, or any other basis covered under applicable law.
At more than 100 award-winning properties worldwide, The...
...assets. Speak with others using clear and professional language. Develop and maintain positive working relationships with others;... ...disability and veteran status, or any other basis covered under applicable law.
At more than 100 award-winning properties worldwide, The...