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1 Apply advanced understanding of the application of cGMPs for aseptically produced generic drug products from to early development through ANDA approvalbr two Perform compliance audits of external contractors and vendors and issue audit reportsbr three Work on issues of diverse scope where analysis of situations or data requires evaluation of a variety of factors, including an understanding an...

testsbr three Coach and mentor staff in all aspects of their job performancebr four Develop QC work plans and assign tasks as required to support the manufacturing planbr five Monitor biochemical and chemical analyses of product to ensure stabilitybr six Compile data for documentation of test procedures that may include biochemical, chemical assays, stability program testing and formulation stu...

1 Carry out process design projects and support the plant on a daily basisbr2 Assist in closing accounts at the end of the monthbr3 Support day-to-day manufacturing activities, including trouble-shooting problems to ensure safe production of hydrogen peroxide H2O2 and sodium percarbonate PCSbr4 Conceive money savings projects as well as design and progress such projectsbr5 Drive and assist HSE ...

questions Want to know the Compensation range Keep reading. br br The best way to get more information is to click Apply, upload your resume, and ENTER YOUR QUESTIONS in the Introductory letter field. A recruiter will call you and answer all of your questions if they feel you are a fit for the role. Your resume will be kept CONFIDENTIAL we respect your privacy. Our Recruiters are more likely to...

tise or support related to quality and manufacturingp p4 Determine root causes of failures using statistical methods and recommend changes in processing methodsp p5 Incorporate new methods and processes to improve existing operationsp p6 Train personnel in new or existing methods while maintaining compliance with workplace standards and policiesp p7 Develop and execute standardized work with vi...

pPartial Job Descriptionp p1 The Manager Quality Assurance Product Development provides leadership in support of quality systems for development, clinical, and commercial pharmaceutical activities to ensure organizational compliance with global regulatory qualifications and guidelines FDA, ICH, EU, WHO, etc., and quality activities including Quality Assurance and Quality Control.p p2 Provide le...

duct developmentsp p4 Prepare manufacturing documentation pbr More questions Want to know the Compensation range Keep reading. br br The best way to get more info is to click Apply, upload your resume, and ENTER YOUR QUESTIONS in the Introductory letter field. A recruiter will call you and answer all of your questions if they feel you are a fit for the role. Your resume will be kept CONFIDENTIA...

pPartial Job Descriptionp p1 Develop departmental strategy to implement continuous improvements, determine optimum equipment based on performance and cost and prioritize engineering staffs projectsp p2 Manage and track capital projectsp p3 Ensure that goals and milestones are met on time and within budgetp p4 Manage capital projects within the manufacturing area, process and equipment validatio...

pPartial Job Descriptionp p1 Design, implement and improve manufacturing processes to produce cost effective quality productsp p2 Work with Engineering to ensure efficient transfer of product design to manufacturingp p3 Use principles and theories of science, engineering and mathematics to solve technical problemsp p4 Assist engineers, or under the direction of engineering department, design, d...

ys goalsp p3 Set departmental priorities, goals and objectivesp p4 Maintain and improve the quality systems effectiveness and the systems compliance with regulations and standardsp p5 Assist departmental employees in defining and reaching development goalsp p6 Take responsibility for directing failure analysis on products and materials and provide trend data to prioritize corrective actionp p7 ...

pPartial Job Descriptionp p1 Develop and maintain a system to ensure that all products manufactured by the organization meet customer and company specificationsp p2 Minimize cost of non-conformancep p3 Follow all company established methods, policies, rules, practices and procedures to ensure employee safety, product quality and efficient operationsp p4 Develop improvements and manage quality a...

pPartial Job Descriptionp p1 Display a solid understanding of theoriespractices utilized by other disciplines outside primary area of expertisep p2 Effectively operate in and may facilitate cross-functional teams with guidancep p3 Plan, manage and implement electrical and controls related projectsp p4 Implement administration and control of the documentation used to describe sterilization, fill...

p4 Communicate and coordinate with other departments and customers as required for quality related issuesp p5 Manage the review and approval of Production Batch Records and QC testing records for final product releasep p6 Ensure quality systems are compliant and efficientp p7 Manage customer and FDA audits and the PAI preparationp p8 Take responsibility for elaboration of regulatory company str...

pPartial Job Descriptionp p1 Manage the personnel, material resources and operations of the Microbiology and Chemicals quality control department to ensure conformance to all regulatory, quality system, internal and external customer requirementsp p2 Develop, implement and monitor the performance of quality control processes, personnel and methods to ensure reagents, in-process and raw material...

pPartial Job Descriptionp p1 Manage the design, specification and installation of new and renovated biopharmaceutical process equipmentp p2 Provide engineering support and issue solving for existing equipment and manufacturing processesp p3 Design and specify cGMP process and utility equipment, piping and controlsp p4 Manage projects related to process and utility equipment and manufacturingp p...

ions and manage the GxP training of employees pbr More questions Want to know the Compensation range Keep reading. br br The best way to get more info is to click Apply, upload your resume, and ENTER YOUR QUESTIONS in the Introductory letter field. A recruiter will call you and answer all of your questions if they feel you are a fit for the role. Your resume will be kept CONFIDENTIAL we respect...

pPartial Job Descriptionp p1 Responsible for the design, implementation and management of design development programs, from concept through product release in an ISO 134852003 and FDA QSR environment. This will include training the appropriate personnel on company design development processes and procedures.p p2 Assist in creating design development program quality plans, including program phas...

verse regulated environment. br four Head the quality organization that oversees GMP, GLP and GCP regulatory compliance for specified products, working with both direct and indirect reports across the organization. br five Includes process and analytical method development and validation activities, manufacturing of API and drug products, packaging and distribution of clinical supplies, oversig...

es as neededp p3 Work cross functionally to ensure the resolution of problems and actions as neededp p4 Facilitate the development and continual improvement of CMS procedures with special focus on Quality Inspection and NCM processingp p5 Identify potential product or process nonconformances communicate and escalate utilizing CAPA as neededp p6 Conduct quality inspectionsp p7 Develop receiving ...

pPartial Job Descriptionp p1 Identify and assess regulatory risks for the local and, if applicable, global Healthcare business unit in conjunction with the VP of Quality and Regulatory Affairsp p2 Provide local Regulatory and QA guidance and investigation on internal shared Quality and Regulatory teams, including Material Review Board, Complaint Handling Unit and Document Change Request teamsp ...