Reporting to the Senior Manager, Quality Control the successful candidate will perform a variety of microbiological related functions and will be part of a team responsible for ensuring the integrity of the microbiology laboratory within a sterile GM environment. The ideal candidate will have a strong GMP background in the Pharmaceutical Industry and experience managing staff.
This is a full-time, permanent position. Due to the nature of the role, weekend work and additional hours may be required from time-to-time to meet project requirements.
• Establish and oversee all environmental and microbiology related programs• Plan and prioritize microbiological testing activities and provide leadership to the Microbiology team.• Compile, trend and interpret data for release and environmental monitoring testing• Support method verification and validation activities by authoring and/or reviewing - protocols, coordinating testing, and reviewing reports according to appropriate guidelines• Ensure Quality Control equipment is qualified and calibration status is maintained• Participate and/or lead investigations with strong understanding of compliance and cGMPs, strong scientific judgment and leadership in decision making• Provide expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests, and improvement initiatives within the microbiological team’s remit• Support continuous improvement activities related to Quality Control and compliance• Support regulatory activities including, but not limited to, regulatory inspections and filings related to general analytical methodologies• Work collaboratively with the QC management team to discuss department objectives and planning strategies
KNOWLEDGE, SKILLS AND ABILITIES
• Degree/Masters’ Degree in Microbiology or recognized qualification in microbiology required• 5-10 years or more relevant work experience in pharmaceutical or biological manufacturing industry with more than 2 years managing a team• Good working knowledge of aseptic techniques and good documentation practices• Have working knowledge of US and EU Good Manufacturing Practices (GMPs) and other international GMP standards such as ICH, PIC/S. • Have experience with execution of USP and EP test methodology (Microbial, Sterility, Endotoxin, Growth Promotion) for the manufacture of sterile products and design and implementation of environmental monitoring programs.• Understanding of 5S methodology and able to transform an area using 5S methodology• Experience in analytical method verification, validation and transfer• Must be able to gown as required in manufacturing areas• Sound judgement to identify when an issues need to escalated to management • Excellent interpersonal (verbal and written) skills, detail oriented and organized and methodical in planning, scheduling and execution of tasks• Ability to problem solve with sound analytical thinking • Strong sense of pride in ownership and quality of work• Experience working in a start-up environment would be an asset