astons

Lead Technician (Overseas Training / New Sterile Plant / Joo Koon)

Thermo Fisher Scientific
Full Time: $3000 - $4000 / month

Job Description

How Will You Make an Impact?

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

What will you do?

The incumbent will assist manager to supervise a team to meet production targets/schedules while always maintaining standards of cGMP, safety, and housekeeping. Along with this the incumbent will perform various tasks and activities listed below for which they are appropriately trained and are in compliance with the cGMP, company and department SOPs and the safety regulations.

Responsibilities

1. Monitor the production activities and ensure that processes are performing as per process description and SOPs. Responsible to complete batch documentation accurately and thoroughly, while adhering to the quality and safety standards, and maintaining a productive, cost-effective process.

2. Assist the Production Leader in the day-day production activities. Approve the required production cycles.

3. Assist and ensure optimum allocation of personnel and equipment. Liaison with associated departments for day-day issues.

4. Report and assist to investigate quality deviations. Assist in troubleshooting of related quality deviations and resolving problems that arise during the processing.

5. Ensure correctness of completed batch sheets and the timely submission of the same.

6. Ensure adherence to cGMP and GDP (Good Documentation Practice).

7. Approve and closeout safety work permit.

8. Attend team meetings and other meetings as required.

9. Provide oversight during preventive and breakdown maintenance. This includes providing Operations oversight of CM/PM/Calibration activities in the production area.

10. Lead Continuous Improvement activities as assigned by manager to improve Quality as well as Efficiency.

11. If required, setup and operate pharmaceutical production equipment including high-speed filling lines for sterile products, fully automatic Lyophilizser, Autoclave, parts and vial washers, depyrogenation tunnel, Formulation process, HMI and automatic CIP/SIP processes and inspection and packaging line equipment (e.g. AVIM, labelling and carton machine etc.) as per relevant SOPs and the Batch Record.

12. If required, perform formulation activities of production batches as per relevant SOPs and the Batch Record. This includes formulation and/or dispensing of all the available Drug substance(s) and excipients. Complete all the relevant training before executing any task all the time and every time.

13. Responsible to perform all the materials and process (SAP) transactions at each manufacturing process steps as per relevant SOPs and the Batch Record.
For aseptic operations strictly follow aseptic techniques and practices practice as per relevant SOPs.

14. If required, carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area as per relevant SOPs and the Batch Record.

15. If required, perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing (e.g. bioburden sampling, waler sampling). If applicable, perform chemical and physical tests during the processing of the batch (e.g. pH testing).

16. If required, prepare filters for test execution and perform FIT (filter Integrity testing) as per relevant SOPs and the Batch Record. Follow safety and quality compliance at all times and communicate in a timely manner to the superior if any anomalies are observed.

17. Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.

18. Perform all tasks in accordance with the standard operating procedures and maintain strict compliance to GMP at all times. Report all the quality issues immediately to Manager or Lead technician.

19. If required and depending on product requirement, perform chemical and mathematical calculations to determine product potency and endotoxin levels for each batch formulation.

20) Any other duties as and when assigned by the Manager.

Interested applicants please apply via the following link 
https://jobs.thermofisher.com/global/en/job/192314BR/Lead-Technician

Join our Talent Community for exciting career opportunities!
https://jobs.thermofisher.com/global/en/jointalentcommunity

   

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