Supervisor, Microbiology
7 months ago
Cosmetica is recognized for innovation, excellence, and commercialization with award-winning products. From concept to creation, we offer an unparalleled array of services that will inspire, create and deliver every step of the way. We value and recognize talent and want you to help us create beauty in the world At Cosmetica Laboratories, we are committed to growing our internal employees and developing them to become the best version of themselves.
Role Purpose
**This role is primarily responsible for**:
- To supervise specific microbiologically related functions with the company’s quality program
- overseeing the microbial testing of raw materials, bulk, and finished products
- To make sure that awareness in microbiology is implemented in whole organization by assisting in GMP compliance activities within the whole facility.
**Key Accountabilities**:
**Primary Responsibilities**:
- Overseeing operations in the microbiology lab; ensuring that everything is in compliance with the company standard, GMP, and customer requirements.
- Responsible for environmental monitoring program (Plant and Microbiology Lab.), sanitation, and plant hygiene program within the whole facility and microbiology lab.
- Supervise the microbiological testing of raw materials, bulk, and finished goods, and purified water according to established methods; maintain the documentation control on microbial analysis and other related tasks
- Investigate Out of specs (OOS) and OOT (Out Of Trend) micro test results, initiate CAPA, and ensures that corrective action has been taken by stakeholders.
- Develop the quality incident and planned deviation approval reports, and change control as per requirements.
- Maintain inventory control of lab supplies and monitor the equipment maintenance program.
- Take initiatives to improve the methods and processes in the micro lab from a cost, labor and time savings perspective.
- Trains and qualifies Microbiologist/Technician for standard test procedures and methods.
- Assists in GMP-related activities including GMP compliance, writing SOPs, WIs and C&S validation, and internal audits.
- Assists in hosting micro-risk assessments or quality audits, coordinates action plans for concerned individuals based on self-inspection, and makes follow-ups.
- Assists in promoting Micro or GMP awareness programs and compliance with QA Key Elements
- Writes, reviews, and approves SOP in micro-related activities
- Review micro-related documents and records and keeps them for future references
- Validate/verify the existing Microbial testing methods and or methods as per ISO/USP for cosmetics and OTC drug products
- Deals with client Microbiologist with regards to any micro requirements and follow-ups
- Responsible for initiating/approving purchasing requests (PRE) as per microbiology lab requirements.
- Responsible for observing and releasing the microbial content test results, and releasing documents.
- Follows Health and Safety rules and regulations
- Conduct microbial testing due to any unforeseen circumstances
- Perform any task assigned by the quality control manager
**Secondary Responsibilities**:
- Perform risk assessment on new formulas, micro-related processes, and when commissioning the new equipment in GMP areas.
- Assist R&I analytical lab in developing the microbial specifications of bulk and raw materials
- Assist in the execution of cleaning and sanitization validation studies for major equipment
- Performs other QAQC-related activities when required
- Assist in making sure that the plant operation is in compliance with GMP
**Skills, Experience, and Education Required**:
- Bachelor of Science in Microbiology, or higher related in Microbiology
- Training and hands-on experience in microbiology and QC/QA functions, WHMIS, and GMP training
- Self-motivated
- Highly organized with the ability to work in a fast-paced environment
- Strong interpersonal, communication, and time management skills
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