QC Manager - Environmental Monitoring
We are currently partnering with an award-winning biotech company with global presence across the US, Europe and APAC regions. Using their proprietary gene-editing and cell therapy platform and deep scientific expertise, they design and engineer a diverse portfolio of inspired cell solutions for pharmaceutical, biotechnology, diagnostic/clinical laboratory, and academic institutions across the globe.
In conjunction, recent expansions into the APAC region has then created a rewarding and exciting opportunity for a Quality Control Manager with experience in Environmental Monitoring. As a seasoned technical and scientific professional, you will ideally have broad technical understanding of entire portfolio and come up with best practises to improve current working approaches within the organization
Reporting in to the Senior Manager in QC, you will also be assuming the following responsibilities:
- Responsible in ensuring all equipment and methods used for EM are being qualified and/or validated together with implementing EM programs
- Responsible in ensuring that the EM trend reports are being developed and the trend information is being shared with the site Quality team
- Drives corrective/preventative actions, ensuring work is complete and the site remains in a state of control.
- Responsible for ensuring laboratory compliance and data integrity in all areas within the scope of EM and LS.
- Lead the QC Environmental Monitoring (EM) Team and QC Lab Support (LS) Team
- Lead the QC Lab Support Team which supports areas such as Sample Management, Sample Shipment Coordination, QC inventory management, Stability Samples Management and reagents preparation.
- Ensure the necessary training within the department is carried out effectively.
- Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems.
- Reviews records for accuracy and compliance with cGMP and Tessa policies and SOPs.
- Lead/participate in EM excursion investigations.
- Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings.
- Writes, reviews, and/or approves SOPs, sampling plans, and protocols.
- Provides technical expertise in the areas of environmental monitoring.
- Proactively evaluate the laboratory's quality systems for gaps in current compliance standards and/or industry trends for compliance
- Approve and authorize specifications, sample instructions, methods and other Quality Control procedures, including changes
- Coach and provide feedback on job performance
- Complete annual performance evaluations and identify development opportunities.
- Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints likewise CAPA
- Develops and monitors team performance
- Identify, develop, track performance metrics to effectively monitor laboratory performance and customer support.
- Monitors and evaluates current regulatory requirements, making recommendations for improvements when necessary.
- Degree in life science discipline or any related field with at least 5 years of relevant working experience environmental monitoring in a highly regulated cGMP regulated environment
- Exposure in a Biotechnology or Pharmaceuticals industry with at least 2 years of supervisory experience would be desirable
- Good understanding of current regulatory requirements of GMP Biologics and Pharmaceutical industries.
- Experience with cleanroom environmental monitoring especially in the areas of aseptic GMP manufacturing.
- Demonstrate strong leadership, communication and organizational skills
- Experience with technical investigations.
- Ability to prioritize work and multitask.
- A demonstrated ability to supervise, train, and manage technical staff.
- cGMP audit experience in USFDA, EU and HSA
Feel that you have what it takes? Simply hit the "Apply" button and include your updated CV alongside with it. Alternatively, if you know someone suitable, get them to include your details in the application and stand a chance to win shopping vouchers through our Referral Rewards Program. Do note that only shortlisted candidates will be notified
EA License No: 11C5502 | EA Reg No: R1985488