pharmaceutical industry?
Do you have experience of microbiology testing including Sterility,
endotoxin, mycoplasma and Environmental Management?
If you have the relevant experience, please forward your CV to (Please
contact us using the "Apply for this Job Posting" box below) for
review or to discuss in confidence.
MICROBIOLOGY ANALYST- CELL THERAPY - DUBLIN WEST - DUBLIN
JOB DESCRIPTION
OUR CLIENT IS ONE OF THE WORLD**APPLY ON THE WEBSITE**;S LARGEST
PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES AND HAS MULTIPLE
MANUFACTURING SITES ACROSS IRELAND.
WITH MAJOR CAPITAL INVESTMENT HAPPENING IN THEIR PLANTS, THIS IS AN
EXCITING TIME TO JOIN THE TEAM.
YOU WILL BE RESPONSIBLE FOR OVERSIGHT OF THE MICROBIOLOGY LABORATORY
SUPPORTING THE MANUFACTURE OF A CELL THERAPY PRODUCT.
OVERSEE ASEPTIC PRACTICES (GOWNING, MONITORING, CLEANING AND RELATED
TRAINING).
PERFORM MICROBIOLOGICAL TESTING AS REQUIRED TO SUPPORT OPERATIONS.
PERFORM ENVIRONMENTAL MONITORING AS REQUIRED TO SUPPORT OPERATIONS.
ENSURE THAT THE MICROBIOLOGY LABORATORY IS SET UP AND OPERATES IN
COMPLIANCE WITH CURRENT GOOD LABORATORY PRACTICE / GOOD MANUFACTURING
PRACTICE AT ALL TIMES.
IMPLEMENT AND MAINTAIN STANDARDS OF GLP AND ANALYTICAL PRACTICE
CONSISTENT WITH CURRENT REGULATORY EXPECTATIONS AND GLOBAL STANDARDS.
ENSURE THAT TESTING SCHEDULES ARE ACHIEVED AND MANAGE LABORATORY
RESOURCES (INSTRUMENTS AND PERSONNEL) TO PROVIDE A COMPREHENSIVE
ANALYTICAL SERVICE FOR TESTING OF ALL SAMPLES.
OVERSEE THE CELL MANUFACTURING FACILITY ENVIRONMENTAL MONITORING
PROGRAMME FOR THE FACILITY.
PARTICIPATE IN THE TECHNICAL TRANSFER / VALIDATION OF MICROBIOLOGICAL
TESTING PROCEDURES INCLUDING MYCOPLASMA, STERILITY TESTING AND
ENDOTOXIN TESTING.
MANAGE THE INVESTIGATION INTO ANY NON-CONFORMANCE, INSTRUMENT
MALFUNCTION, ACCIDENT OR OTHER ABNORMAL OCCURRENCE.
MANAGE AN EFFECTIVE LABORATORY DOCUMENTATION SYSTEM.
PREPARE FOR, AND SUPPORT, INTERNAL AND EXTERNAL AUDITS (E.G. HPRA,
FDA, CORPORATE, CUSTOMER).
REQUIREMENTS
3+ YEARS? EXPERIENCE WORKING IN MICROBIOLOGY IN THE PHARMACEUTICAL
INDUSTRY, PREFERABLY IN A BIOLOGICS COMPANY
EXPERIENCE OF MICROBIOLOGY TESTING INCLUDING STERILITY, ENDOTOXIN,
MYCOPLASMA AND ENVIRONMENTAL MANAGEMENT
THOROUGH KNOWLEDGE OF GMP AND CURRENT FDA & EMEA REGULATIONS
KNOWLEDGE AND EXPERIENCE OF LEAN LABORATORIES IS PREFERABLE
PREVIOUS EXPERIENCE IN SETTING UP A NEW MICROBIOLOGY LABORATORY IS
DESIRABLE
STRONG MICROBIOLOGY KNOWLEDGE, WITH THE ABILITY TO ACT AS A SUBJECT
MATTER EXPERT
PACKAGE
?**APPLY ON THE WEBSITE** - **APPLY ON THE WEBSITE**K PER ANNUM,
DEPENDENT ON EXPERIENCE
EXCELLENT BENEFITS PACKAGE
PERFORMANCE RELATED BONUS
HEALTH INSURANCE
PENSION
FLEXIBILITY
PAID MATERNITY/PATERNITY LEAVE
EDUCATIONAL ASSISTANCE PROGRAMME
ZERO ABSENCE AWARD
TALENT & DEVELOPMENT PROGRAMME
OCCUPATIONAL HEALTH & WELLNESS PROGRAMME
Do you have 4+ years of experience working in Microbiology in the
pharmaceutical industry?
Do you have experience of microbiology testing including Sterility,
endotoxin, mycoplasma and Environmental Management?
If you have the relevant experience, please forward your CV to (Please
contact us using the "Apply for this Job Posting" box below) for
review or to discuss in confidence.
MICROBIOLOGY ANALYST- CELL THERAPY - DUBLIN WEST - DUBLIN
JOB DESCRIPTION
OUR CLIENT IS ONE OF THE WORLD**APPLY ON THE WEBSITE**;S LARGEST
PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES AND HAS MULTIPLE
MANUFACTURING SITES ACROSS IRELAND.
WITH MAJOR CAPITAL INVESTMENT HAPPENING IN THEIR PLANTS, THIS IS AN
EXCITING TIME TO JOIN THE TEAM.
YOU WILL BE RESPONSIBLE FOR OVERSIGHT OF THE MICROBIOLOGY LABORATORY
SUPPORTING THE MANUFACTURE OF A CELL THERAPY PRODUCT.
OVERSEE ASEPTIC PRACTICES (GOWNING, MONITORING, CLEANING AND RELATED
TRAINING).
PERFORM MICROBIOLOGICAL TESTING AS REQUIRED TO SUPPORT OPERATIONS.
PERFORM ENVIRONMENTAL MONITORING AS REQUIRED TO SUPPORT OPERATIONS.
ENSURE THAT THE MICROBIOLOGY LABORATORY IS SET UP AND OPERATES IN
COMPLIANCE WITH CURRENT GOOD LABORATORY PRACTICE / GOOD MANUFACTURING
PRACTICE AT ALL TIMES.
IMPLEMENT AND MAINTAIN STANDARDS OF GLP AND ANALYTICAL PRACTICE
CONSISTENT WITH CURRENT REGULATORY EXPECTATIONS AND GLOBAL STANDARDS.
ENSURE THAT TESTING SCHEDULES ARE ACHIEVED AND MANAGE LABORATORY
RESOURCES (INSTRUMENTS AND PERSONNEL) TO PROVIDE A COMPREHENSIVE
ANALYTICAL SERVICE FOR TESTING OF ALL SAMPLES.
OVERSEE THE CELL MANUFACTURING FACILITY ENVIRONMENTAL MONITORING
PROGRAMME FOR THE FACILITY.
PARTICIPATE IN THE TECHNICAL TRANSFER / VALIDATION OF MICROBIOLOGICAL
TESTING PROCEDURES INCLUDING MYCOPLASMA, STERILITY TESTING AND
ENDOTOXIN TESTING.
MANAGE THE INVESTIGATION INTO ANY NON-CONFORMANCE, INSTRUMENT
MALFUNCTION, ACCIDENT OR OTHER ABNORMAL OCCURRENCE.
MANAGE AN EFFECTIVE LABORATORY DOCUMENTATION SYSTEM.
PREPARE FOR, AND SUPPORT, INTERNAL AND EXTERNAL AUDITS (E.G. HPRA,
FDA, CORPORATE, CUSTOMER).
REQUIREMENTS
3+ YEARS? EXPERIENCE WORKING IN MICROBIOLOGY IN THE PHARMACEUTICAL
INDUSTRY, PREFERABLY IN A BIOLOGICS COMPANY
EXPERIENCE OF MICROBIOLOGY TESTING INCLUDING STERILITY, ENDOTOXIN,
MYCOPLASMA AND ENVIRONMENTAL MANAGEMENT
THOROUGH KNOWLEDGE OF GMP AND CURRENT FDA & EMEA REGULATIONS
KNOWLEDGE AND EXPERIENCE OF LEAN LABORATORIES IS PREFERABLE
PREVIOUS EXPERIENCE IN SETTING UP A NEW MICROBIOLOGY LABORATORY IS
DESIRABLE
STRONG MICROBIOLOGY KNOWLEDGE, WITH THE ABILITY TO ACT AS A SUBJECT
MATTER EXPERT
PACKAGE
?**APPLY ON THE WEBSITE** - **APPLY ON THE WEBSITE**K PER ANNUM,
DEPENDENT ON EXPERIENCE
EXCELLENT BENEFITS PACKAGE
PERFORMANCE RELATED BONUS
HEALTH INSURANCE
PENSION
FLEXIBILITY
PAID MATERNITY/PATERNITY LEAVE
EDUCATIONAL ASSISTANCE PROGRAMME
ZERO ABSENCE AWARD
TALENT & DEVELOPMENT PROGRAMME
OCCUPATIONAL HEALTH & WELLNESS PROGRAMME
We need : English (Good)
Type: Permanent
Payment:
Category: Others