About PSC BiotechWho we are?PSC Biotech is a leading Biotech
Consultancy firm founded in **Apply on the website**, headquartered in
Pomona, California, USA, with Global operations in Ireland, India,
Singapore, Australia and the US, serving **Apply on the website**
clients in more than **Apply on the website** countries worldwide. We
provide cloud-based software solutions for Quality Management and
Regulatory Inspections, pharmaceuticals contract manufacturing
professionals, and metrology services to our clients.?Take your
Career to a new Level?PSC Biotech disrupts the conventional
consultancy model by aligning our EVP as one of the unique selling
point which includes the opportunity to work with the most talented
cohort of like-minded professionals operating in the Pharma/ Biotech
Industry. We offer a permanent contract of employment giving exposure
of working in Top Pharmaceutical client sites in a diverse-cultural
work setting.Employee Value PropositionEmployees are the
?heartbeat? of PSC Biotech, we provide unparalleled empowering
career development though Learning & Development in-house training
mentorship through constant guidance to facilitate career progression.
We believe in creating high performing teams that can exceed our
client?s expectations with regards to quality of all scalable and
business unit deliverables, staying under budget and ensuring
timelines for our deliverables are being met.)Microbiology Analyst
role is a criticallyimportant activity, ensuring efficient and
effective compliant design,construction, qualification, and operation
of the new strategic DrugSubstance facility.This positionwill be
responsible for qualifying the Microbiology Quality Control lab and
thetransfer of Microbiological analytical methods including but not
limited tocutting edge Rapid Microbiological Methods. This person will
be key in thelayout of the lab testing flow to ensure the process is
streamlined and in linewith lean principles. Additional development
opportunities within the microand chemistry lab will be strongly
considered to recognize the tremendous valueof knowledge / experience
gained by the candidate during the project phases. To maximize the
development opportunity,the candidate will be the key talent in
analytical Microbiology techniques andin current Pharmacopeia methods.
RESPONSIBILITIES:
* The motivationto be an inspiring member of a high performing team.
* The desire tocontinuously learn, improve and develop.
* Perform supporting activities for general lab readiness,laboratory
equipment qualification and method transfers.
* Perform and carry out a variety of routine microbiological
analyticaltechniques including but not limited to environmental
monitoring, WFI testing, growthpromotion testing, In-process product
testing, Final product testing such asbioburden and both Kinetic
turbidimetric and MCS rapid endotoxin testing incompliance with GMP
requirements.
* To integrate and complete all documentation on time and befamiliar
with LIMS.
* To train and be trained in the use of Rapid microbiologytechniques
including but not limited to endotoxin testing, water
bioburdentesting, E.M testing, absence of bioburden testing and
identification testing.
* Follow up-to-date analytical practices with reference
topharmacopoeias, specifications, regulations and industry standards.
* To update SOP?s and write protocols as required.
* Support the laboratory testing schedule to achieve anefficient QC
system.
* Receive and manage samples that come into the lab forstability,
in-process and release testing.
* Reagent preparation, cleaning, and routine equipmentmaintenance.
* Maintain good housekeeping and GLP within the laboratory.
* Calibrate and maintain all designated laboratoryinstruments.
* Participate inrisk assessments, inspections, audits, incident
investigations, etc. andimplement and follow-up on corrective /
preventative measures.
* Ensure training is current for all job functions performed.
* Assist in training new QC Analysts on routine procedures
andpractices.
* Order, stock and receive laboratory supplies.
* Maintain data integrity and ensure compliance with companySOPs,
specifications and cGMP regulations.
* Ensure that cGMP standards are maintained at all times.
* Delivery ofarea performance to meet or exceed performance or
quality goals.
* Promote andparticipate in the implementation and maintenance of
the relevant safety programmes.
* Participate andComply with the Quality Management System
requirements.
* Responsible fordriving a culture of Continuous Improvement by
deploying Six Sigma tools.
* This positionwill be shift work
REQUIREMENTS
* Degreequalification (Science/Quality/Technical).
* PreferenceLean Six Sigma
* **Apply on the website** yearsindustry experience with significant
knowledge and experience in working in a microbiologylab unit and
working with contract labs.
* Experience in compendial testing for water and
environmentalmonitoring in clean room environments.
* Working knowledge of QC Systems (Empower, LIMS,Trending systems.)
* Ability to respond to changing priorities.
* Strong organisational skills.
* Good aseptic technique and awareness of contaminationcontrol.
* Good verbal and written communication skills.
* Troubleshooting and problem-solving skills.
* Good attention to detail.
* Ability to think logically and be proactive.
* Ability to work as part of a team and on own initiative in
aconstructive manner.
* Flexible and self-motivated.
JOB DESCRIPTION
About PSC BiotechWho we are?PSC Biotech is a leading Biotech
Consultancy firm founded in **Apply on the website**, headquartered in
Pomona, California, USA, with Global operations in Ireland, India,
Singapore, Australia and the US, serving **Apply on the website**
clients in more than **Apply on the website** countries worldwide. We
provide cloud-based software solutions for Quality Management and
Regulatory Inspections, pharmaceuticals contract manufacturing
professionals, and metrology services to our clients.?Take your
Career to a new Level?PSC Biotech disrupts the conventional
consultancy model by aligning our EVP as one of the unique selling
point which includes the opportunity to work with the most talented
cohort of like-minded professionals operating in the Pharma/ Biotech
Industry. We offer a permanent contract of employment giving exposure
of working in Top Pharmaceutical client sites in a diverse-cultural
work setting.Employee Value PropositionEmployees are the
?heartbeat? of PSC Biotech, we provide unparalleled empowering
career development though Learning & Development in-house training
mentorship through constant guidance to facilitate career progression.
We believe in creating high performing teams that can exceed our
client?s expectations with regards to quality of all scalable and
business unit deliverables, staying under budget and ensuring
timelines for our deliverables are being met.)Microbiology Analyst
role is a criticallyimportant activity, ensuring efficient and
effective compliant design,construction, qualification, and operation
of the new strategic DrugSubstance facility.This positionwill be
responsible for qualifying the Microbiology Quality Control lab and
thetransfer of Microbiological analytical methods including but not
limited tocutting edge Rapid Microbiological Methods. This person will
be key in thelayout of the lab testing flow to ensure the process is
streamlined and in linewith lean principles. Additional development
opportunities within the microand chemistry lab will be strongly
considered to recognize the tremendous valueof knowledge / experience
gained by the candidate during the project phases. To maximize the
development opportunity,the candidate will be the key talent in
analytical Microbiology techniques andin current Pharmacopeia methods.
RESPONSIBILITIES:
* The motivationto be an inspiring member of a high performing team.
* The desire tocontinuously learn, improve and develop.
* Perform supporting activities for general lab readiness,laboratory
equipment qualification and method transfers.
* Perform and carry out a variety of routine microbiological
analyticaltechniques including but not limited to environmental
monitoring, WFI testing, growthpromotion testing, In-process product
testing, Final product testing such asbioburden and both Kinetic
turbidimetric and MCS rapid endotoxin testing incompliance with GMP
requirements.
* To integrate and complete all documentation on time and befamiliar
with LIMS.
* To train and be trained in the use of Rapid microbiologytechniques
including but not limited to endotoxin testing, water
bioburdentesting, E.M testing, absence of bioburden testing and
identification testing.
* Follow up-to-date analytical practices with reference
topharmacopoeias, specifications, regulations and industry standards.
* To update SOP?s and write protocols as required.
* Support the laboratory testing schedule to achieve anefficient QC
system.
* Receive and manage samples that come into the lab forstability,
in-process and release testing.
* Reagent preparation, cleaning, and routine equipmentmaintenance.
* Maintain good housekeeping and GLP within the laboratory.
* Calibrate and maintain all designated laboratoryinstruments.
* Participate inrisk assessments, inspections, audits, incident
investigations, etc. andimplement and follow-up on corrective /
preventative measures.
* Ensure training is current for all job functions performed.
* Assist in training new QC Analysts on routine procedures
andpractices.
* Order, stock and receive laboratory supplies.
* Maintain data integrity and ensure compliance with companySOPs,
specifications and cGMP regulations.
* Ensure that cGMP standards are maintained at all times.
* Delivery ofarea performance to meet or exceed performance or
quality goals.
* Promote andparticipate in the implementation and maintenance of
the relevant safety programmes.
* Participate andComply with the Quality Management System
requirements.
* Responsible fordriving a culture of Continuous Improvement by
deploying Six Sigma tools.
* This positionwill be shift work
REQUIREMENTS
* Degreequalification (Science/Quality/Technical).
* PreferenceLean Six Sigma
* **Apply on the website** yearsindustry experience with significant
knowledge and experience in working in a microbiologylab unit and
working with contract labs.
* Experience in compendial testing for water and
environmentalmonitoring in clean room environments.
* Working knowledge of QC Systems (Empower, LIMS,Trending systems.)
* Ability to respond to changing priorities.
* Strong organisational skills.
* Good aseptic technique and awareness of contaminationcontrol.
* Good verbal and written communication skills.
* Troubleshooting and problem-solving skills.
* Good attention to detail.
* Ability to think logically and be proactive.
* Ability to work as part of a team and on own initiative in
aconstructive manner.
* Flexible and self-motivated.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
