Quanta part of QCS Staffing’s Post

Commissioning is so much more important than simply getting a facility operational, particularly in the pharmaceutical, life sciences and advanced technology sectors. It safeguards regulatory compliance and ensures a client can meet its operational goals, facilitating early identification of issues and reducing ongoing operating and maintenance costs. At Scitech, we have the unique sector-specific expertise for our commissioning service to add value and assure performance, whether we are providing design and engineering, construction services or whether you are using a third-party supplier. We have technical expertise building services, including ventilation and air conditioning, mechanical piped services, BMS controls, system commissioning, pharmaceutical facilities commissioning and building commissioning management. Our end-to-end knowledge and expertise make certain that the prerequisites of CQV are fed into from the commissioning stage of your project, ensuring you have the right documentation at the right time and a suitably tested and commissioned building. Find out more: https://lnkd.in/eX8tJVES #Commissioning #CommissioningEngineer #Pharma #Biotech #LifeSciences

Urgent opening for a leadership role in Drug Product Engineering at Malaysia location in one of the leading Pharma company. Role: Drug Product - Engineering Experience: 18+ years Job Description: - To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime. - To raise communication memo for Preventive Maintenance. - To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part. - To respond, carry out and record equipment maintenance activity effectively and efficiently. - Observation and rectification of equipment/ machines condition and detection of unusual conditions ina proactive manner. - Daily reporting of activities and updating any issues at work to the superior. - Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. - To attend, record and conduct all trainings required as per training matrix/ schedule. - Generate various document procedure/protocol/report as and when required. - Fill log sheets/ checklist/ history card/ planner as described in the SOPs. - Follow the established procedures and policies of the company. - Participate in project activity on process optimisation, facility upgrade, or objective. - To propose objectives and targets on work area and comply to set timeline. - Participate in cost and energy management program. - To provide feedback and ensure all the audit findings are closed within the stipulated time. - On routine basis to provide improvement proposal on equipment, process, or quality system. - To authorize the invoice, bills and vouchers for the goods received. - Responsible for data management, trending and periodic presentation. - To prepare shift scheduling. - Evaluate the personnel who have undergone training. - Issue of work permits and gate pass. - To plan/ prepare /review/ approve the preventive maintenance activity/ schedule. - To evaluate and approve on vendor performance/ quality/ capability — vendor evaluation/ management process. - To prepare and achieve team budgets and plan/ performance objectives. - Takes a leadership role in department/ organizations. - Approval of specific equipment for use. - Cost management in budgeting and expenses. - To interview/ managing contract, sub contract works and workers. - Leave and claim approval. - To prepare and plan the material management. - Decision making on priorities. #drugproductengineering #preventivemaintenance #engineering #projects #injectables #formulation #biologics #biotech Interested candidates can share resume on update@biojobz.com

Janssen Gurabo is #hiring! If you have experience in Maintenance & Reliability / Asset Lifecycle Management click below to learn more. You can also connect with Christine Orlando if you have any questions.

Urgent opening for a leadership role in Drug Product Engineering at Malaysia location in one of the leading Pharma company. Role: Drug Product - Engineering Experience: 18+ years Job Description: - To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime. - To raise communication memo for Preventive Maintenance. - To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part. - To respond, carry out and record equipment maintenance activity effectively and efficiently. - Observation and rectification of equipment/ machines condition and detection of unusual conditions in a proactive manner. - Daily reporting of activities and updating any issues at work to the superior. - Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. - To attend, record and conduct all trainings required as per training matrix/ schedule. - Generate various document procedure/protocol/report as and when required. - Fill log sheets/ checklist/ history card/ planner as described in the SOPs. - Follow the established procedures and policies of the company. - Participate in project activity on process optimisation, facility upgrade, or objective. - To propose objectives and targets on work area and comply to set timeline. - Participate in cost and energy management program. - To provide feedback and ensure all the audit findings are closed within the stipulated time. - On routine basis to provide improvement proposal on equipment, process, or quality system. - To authorize the invoice, bills and vouchers for the goods received. - Responsible for data management, trending and periodic presentation. - To prepare shift scheduling. - Evaluate the personnel who have undergone training. - Issue of work permits and gate pass. - To plan/ prepare /review/ approve the preventive maintenance activity/schedule. - To evaluate and approve on vendor performance/ quality/ capability – vendor evaluation/ management process. - To prepare and achieve team budgets and plan/ performance objectives. - Takes a leadership role in department/ organizations. - Approval of specific equipment for use. - Cost management in budgeting and expenses. - To interview/ managing contract, sub contract works and workers. - Leave and claim approval. - To prepare and plan the material management. - Decision making on priorities. #drugproductengineering #preventivemaintenance #engineering #projects #injectables #formulation #biologics #biotech Interested candidates can share resume on update@biojobz.com

Most of us struggle to understand the difference. Did you know that Commissioning, Qualification, and Validation are not the same? These terms are crucial in the pharmaceutical industry. Understanding Commissioning: 👉 Commissioning is used for all equipment and systems. 👉 It’s an engineering test to bring a new plant into working condition. 👉 Applies to all equipment in a manufacturing facility. Understanding Qualification: 👉 Qualification is for equipment, piping, ancillary systems, instruments, and utilities. 👉 It’s the documented act of proving that a system is correctly installed and works as expected. 👉 Applies to systems and equipment impacting product quality and patient safety. 👉 Uses system impact assessments, component impact assessments, and risk management tools. Understanding Validation: 👉 Validation is used for processes, procedures, and methods. 👉 Processes must be validated on qualified equipment. 👉 It’s the documented act of proving a process leads to consistent and reproducible results. 👉 Described as “documented scientific proof of consistent performance.” Key Differences: 1) Qualification and Validation are regulatory-focused. 2) Both are subject to change control procedures. 3) They are more rigorous, document-focused, time-consuming, and expensive. Ensure your processes are compliant and efficient. Dive deeper into each term to master your pharmaceutical operations.

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this document shows clear Differentioon

#Validation VS #Calibration Validation and calibration are two important processes that ensure the accuracy, reliability, and compliance of equipment, systems, and processes. While both processes are essential for maintaining quality standards, they have distinct differences. Validation: 1. Definition: Validation is the process of establishing documented evidence that a system or process consistently produces results meeting predetermined specifications and quality attributes. 2. Purpose: The main objective of validation is to ensure that a system or process consistently meets its intended purpose and performs as expected. 3. Scope: Validation encompasses a wide range of activities, including equipment #Qualification, #processvalidation, #cleaningvalidation, #computer system validation, etc. 4. Documentation: Validation requires comprehensive documentation to demonstrate compliance with regulatory requirements. This includes protocols, reports, standard operating procedures (SOPs), and other relevant documents. 5. Frequency: Validation is typically performed during the initial setup or installation of equipment/systems/ processes and periodically thereafter to ensure continued compliance. 6. Regulatory Compliance: Validation is a regulatory requirement in the pharmaceutical industry to ensure product safety and efficacy. Calibration: 1. Definition: Calibration is the process of comparing measurements made by an instrument or device with a known standard to determine its accuracy. 2. Purpose: The primary goal of calibration is to ensure that instruments or devices used for measurement provide accurate and reliable results within specified tolerances. 3. Scope: Calibration focuses on individual instruments or devices used for measurement purposes such as temperature sensors, pressure gauges, balances, #pH meters, etc. 4. Documentation: Calibration requires documentation of calibration procedures followed, calibration certificates issued by accredited laboratories/organizations, and records of calibration history for each instrument/device. 5. Frequency: Calibration is performed at regular intervals based on manufacturer recommendations or regulatory requirements to maintain accuracy over time. 6. Regulatory Compliance: Calibration is also a regulatory requirement in the pharmaceutical industry to ensure accurate measurements during manufacturing processes. Reference: https://lnkd.in/gmzEtpzu Ershad Moradi

What's the difference between Commissioning, Qualification and Validation in the Pharmaceutical Industry? It can be tricky to pin down exactly but we had a go at it and built out this table to illustrate the difference. 👉 Commissioning is normally used for ALL equipment and systems. 👉 Commissioning can be viewed primarily as an engineering test to bring a new plant into working condition and applies to ALL of the equipment in that manufacturing facility. 👉 Qualification is normally used for equipment, piping, ancillary systems, instruments, and utilities. 👉 Qualification is the documented act of proving that a mechanical, piping or other system is correctly installed, meets the design specifications and works as expected under load. It only applies to systems and equipment that have a direct or indirect impact on product quality and patient safety. We determine this by using system impact assessments, component impact assessments and risk management tools. 👉 Validation is normally used for processes, procedures and methods. But processes MUST be validated on qualified equipment. 👉 Validation is a broader term. It is the documented act of proving a process, procedure or method leads to a consistent and reproducible result. It can also be described as “documented scientific proof of consistent performance“. 👉 Both Qualification and Validation differ from Commissioning in that: 1) Both Qualification and Validation will be focused on by the regulatory authorities (FDA, EMA, etc) when they come to approve the medicines that are being manufactured in that facility. 2) Both Qualification and Validation are subject to change control procedures 3) Both are more rigorous, document-focused, time-consuming and expensive processes.