Quality Process Job In Oak Hill, New York, Katalyst Healthcares & Life Sciences

Published 2022-08-10
Expires 2022-09-10
ID #1121186447
Quality Process Job In Oak Hill, New York, Katalyst Healthcares & Life Sciences
United States, New York, Oak Hill,
Published August 10, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Quality process

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 Roles and Responsibilities:

To own, manage, develop, and improve the CAPA and RCA process and metrics

Redesign and simplify the current CAPA process.

Thru performance management ensure CAPAs are closed on time and closure is effective.

Review data from CAPA system to perform deep dives and problem solving to ensure system is working correctly and any risks are escalated

Train, coach, and mentor personnel on correct RCA and CAPA Issuance.

To own, manage, develop, improve, and simplify the site Change Control system.

Ensure all site changes are promptly raised, potential impact is evaluated prior to execution .

Ensure there is a process in place where correct SMEs perform the impact assessments of any change .

Implement frequent governance with all site representatives to ensure change controls are correctly advanced.

Train, coach, and mentors site personnel at all levels on QMS standards, process.

To own, manage, develop, improve, the self-inspection and management monitoring process.

Review data from audit systems to perform deep dives and problem solving to repeat and or critical findings are properly managed.

Ensure self-inspection process is effective to challenge current procedures.

Ensure management monitoring is effective on implementing cGMps and company QMS expectations into the process and shop floor.

Work with deviation, supplier program to support correct RCAs are performed on a timely matter.

Supports TTS program improvement to ensure agile implementation agreements along the supply chain.   

Proven expertise in the management/use of quality systems.

Good understanding of regulatory requirements within all Markets supplied by site; able to interpret and provide consultation to ensure compliance.

Strong analytical, numerical, and reasoning skills.

Excellent technical writing skills, verbal communication skills, and presentation skills.

Experience in auditing; negotiation and facilitation of corrective actions.

Project management skills.

Ability to analyse data, effectively summarize findings and draw conclusions, excellent problem-solving skills.

Good understanding of statistical techniques.

Computer skills.

Detailed orientated.

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    Employer's info

    Katalyst Healthcares & Life Sciences
    Registered on October 7, 2017


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    Information technology (IT) is the application of computers to store, study, retrieve, transmit, and manipulate data, or information, often in the context of a business or other enterprise. IT is considered a subset of information and communications technology (ICT). In 2012, Zuppo proposed an ICT hierarchy where each hierarchy level "contain[s] some degree of commonality in that they are related to technologies that facilitate the transfer of information and various types of electronically mediated communications". The term is commonly used as a synonym for computers and computer networks, but it also encompasses other information distribution technologies such as television and telephones. Several industries are associated with information technology, including computer hardware, software, electronics, semiconductors, internet, telecom equipment, and e-commerce. Humans have been storing, retrieving, manipulating, and communicating information since the Sumerians in Mesopotamia developed writing in about 3000 BC, but the term information technology in its modern sense first appeared in a 1958 article published in the Harvard Business Review; authors Harold J. Leavitt and Thomas L. Whisler commented that "the new technology does not yet have a single established name. We shall call it information technology (IT)." Their definition consists of three categories: techniques for processing, the application of statistical and mathematical methods to decision-making, and the simulation of higher-order thinking through computer programs.

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    Source: https://en.wikipedia.org/