JOB DETAILS:

Background information about the job or company (e.g., role context, company overview)

Abacus Parenteral Drugs Limited is looking for passionate, skilled, and motivated professionals to join our dynamic team across multiple departments.

Responsibilities or duties

To carry out microbiological analysis of finished products, raw materials, primary packaging materials, water and environment monitoring.

• To ensure compliance with current Good Laboratory Practices as laid down in the Quality Control procedures
• Compliance with regulatory requirements & cGMP.
• Ensure that all work undertaken is compliant with all relevant internal standards, quality systems, procedures, accreditations, and methodologies and in line with customer expectations.
• Sampling of finished products, packaging, and raw material and data entry in logbooks.
• Validate/verify the test methods, qualify equipment, and clean room personnel.
• Preparation and quality control of media and diluents used in the lab.
• Perform a bacteria endotoxin test of raw materials, stability study samples and finished products
• Perform a sterility test of finished products, stability study samples and raw materials
• Perform bioburden test on pre-sterilized samples
• Perform Particulate matter count test of finished products and stability study samples
• Perform disinfectant efficacy test
• Environmental monitoring of cleanrooms and supporting areas & trend analysis.
• Identification of microorganisms using selective media and microscopy
• Microbial water analysis analysis as in the SOP
• Good housekeeping to ensure cleanliness and proper organization of the laboratory at all times.
• Reception of standard cultures, preparation of in-house isolates, identification and maintenance.
• Attending trainings and training of staff.
• Proper management of equipment and consumable resources to meet KPI’s in line with company targets.
• Perform microbiological assays of antibiotics.
• Calibrate equipment and liaise with supervisors to ensure all equipment calibrations/service/maintenance requirements are fully up-to-date.
• Microbial examination of non-sterile pharmaceutical samples.
• Daily monitoring of sample under incubation & updating reports.
• Daily monitoring of consumables like media & reagents.
• Fulfilling the tasks according to the daily work plan.
• Participate in quality management systems like the following:
  • OOS Investigation
  • OOT Investigation.
  • Deviation handling.
  • Change control
  • Quality risk management.
  • CAPA Closure.
• Update of records on time.
• Timely and proper communication with staff at all levels.
• Reporting critical escalation on time.
• Use of provided Personal protective wear (overall, gas masks, Head cap, gloves.)
• Identify possible sources of incidents and accidents.

Qualifications or requirements (e.g., education, skills)

BSc Microbiology or Biochemistry

Experience needed

Experience in a pharmaceutical/healthcare industry is an advantage

Any other provided details (e.g., benefits, work environment, team info, or additional notes)

Basic safety training

Basic GMP training

Leadership training

Please send your CV and academic credentials to apdlug.careers@abacuspharma.com