No Relocation Assistance Offered
# 160614 - Sao Bernardo do Campo, Sao Paulo, Brazil

Job Summary:

Support the implementation of a plan for assessing the new and modified formula to ensure all products and processes meet the minimal robustness standards as outlined in QMIC 0037 (MICROBIOLOGICAL APPROVAL ON NEW AND MODIFIED). Also develop and validate the accurate methodology to approve and release raw material and finished product.

Develop and implement a Manufacturing Micro Control program that includes all areas of the manufacturing pilot plant such as raw materials (QMIC 0047), water systems (QMIC 0030), cleaning & sanitization (GQS 045) and micro monitoring and/or Control Point Monitoring (CPM) of defined critical points in the process. The Micro Susceptibility Index must be used to identify areas of risk and monitor progress.

Develop & implement microbiology training for microbiologist, pilot plant, PD and I&S groups.

Principal Duties and Responsibilities:

Responsible for performing all microbiological testing to ensure that all new products in development meet the requirements of QS 023 – Microbiological Control. As well as for assuring that the testing is done in conformance to CP Quality Standards and guidelines.

Maintains the laboratory quality assurance systems to assure validity of data

Collect and analyze data to draw conclusions and recommend actions

Performs microbiological testing in accordance with standard procedure (QMIC's).

Maintain accurate, up to date and concise laboratory records, ensure assigned activities are conducted and documented according to Quality requirements and systems; implement applicable preventive or corrective actions.

 Review and implement the new and revised QMICs (Quality Global Micro procedures) within 45 days.

Participates in failure investigations to collect the necessary samples when appropriate. An analyst working in the GTC should acquire basic knowledge of the Product Development process.

Understand and use basic laboratory safety equipment instructions, precautions in handling and disposing of biological materials, in accordance with local regulations.

Support the product development process by testing products for microbiological robustness and preservative effectiveness.

Support the annual stability testing program.

Support the C&S and Water programs by performing analysis and validations.

Perform sampling and testing of water, environmental air, compressed air and surface swab. 

Conduct the method validation testing to be transferred to the manufacturing site for releasing product and analyzing raw material by conventional and faster (Celsis) methodologists

 Conduct raw material validation and classification as required for raw material qualification program.

 Participate in the calibration and qualification program for all equipment and instruments used in the microbiology Lab.

Follow and coordinate/implement Good Manufacturing Practices and Environmental, Health and Safety (EHS) activities; takes preventive and corrective actions to mitigate potential EHS incidents.

Support the Quality program by executing and ensuring all requirements are in place.

Support the culture maintenance and storage program.

 Write and update as needed Standard operating procedures (SOP's) to document all quality activities.

 Other duties and responsibilities as assigned.

Education, Experience, & Skill Requirements

Bachelor's Degree: Microbiology, Biochemistry, Pharmaceutical, Biology Chemistry or related major

Experience in Pharmaceutical, Cosmetic, or Industrial laboratories

Functional Experience 

Written & spoken English 

Proficiency in Google Suite

Knowledge of analytical, basic statistics and mathematics

Preferred Qualifications:

Master's Degree in Microbiology or Biochemistry

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