QA Specialist for Microbiology and Process

2 semanas atrás

Laguna, Brasil Humanheartnature Tempo inteiro

We are looking for a QA Specialist for Microbiology and Process who shares the same vision and commitment in driving the agenda for quality. Person hired will participate in the examination of specimens using microbiological procedures as function of quality assurance. He/she is responsible for making sure that process areas remains safe and in accordance to Good Manufacturing Practice and other regulatory requirements.

Responsibilities:

  • Verify cleaning and sanitization of equipment, utensils (including pails/orocan and containers), areas and/or rooms that will be used by operations.

  • Conduct analytical testing for bulk samples after compounding and filling (Physico Chemico testing: pH, viscosity, specific gravity, appearance, color, odor etc.).

  • Keep push-button and bulk samples for micro testing.

  • Responsible for ensuring compliance to Good Manufacturing Practice in the production area.

  • Ensure compliance to line clearance prior to production and filling operations.

  • Verify that the temperature and relative humidity (RH) are within specification in all areas of production.

  • Review raw materials dispensing for accuracy of weights of RM and the corresponding RM ticket issued by dispenser.

  • Work with production in ensuring that FGs will meet the micro requirements. The concurrent will also be responsible to ensure compliance to WIP monitoring and completion, productivity targets, monitoring usage of alcohol and other production supplies.

  • Verify compliance to GKI quality requirements on C & S, filling (including coding) and GMP during production. Ensure timely feedback and escalation for any observed non-compliances.

  • Creates Non-Conformity Report (NCR) and ensure that CAPA (Corrective and Preventive Action Plans) are implemented to avoid recurrence.

  • Participates in cross-functional investigation and use promote use of quality control tools to investigate and identify the Root Cause and Corrective/Preventive Action plans.

  • Comply with Good Documentation Practices (GDP).

  • Participates in GMP (Internal Company Audit) and provide required documents for compliance.

  • Stop the production or call-out to QA Head/Chairman of GKI for any non-compliance observes during the production of products.

  • Accountable for providing and helping build the Company by strengthening our culture of shared ownership and bayanihan.

  • Performs any and all other tasks and functions that may be assigned from time to time by his/her superior.

Qualifications:

  • Candidate must possess at least a Bachelor's degree in the field of Microbiology or Biology.

  • Has at least 2 years of experience working as QA in Manufacturing Plant or Pharmaceutical Company.

  • Experience in microbiology a plus.

  • Knowledge in ISO, Quality Management System, GMP audit and process engineering.

  • Strong self-motivation, ability to work independently and with a team environment with strong follow up, organization and prioritization skills.

  • Works with INTEGRITY especially with documentation.

  • Applicants must be residing within vicinity of our manufacturing plant in Carmelray 1, Canlubang, Laguna

  • Guaranteed NO SUNDAY work.

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