Vacancies

ASSISTANT QUALITY MANAGER-MICROBIOLOGY

full-time North Industrial Area 18 Mar 2025

Our client, a leading pharmaceutical manufacturing business, is looking for a highly organised individual to support in the coordination of day-to-day operations of the business as ASSISTANT QUALITY MANAGER-MICROBIOLOGY.

ROLE PROFILE

The ideal candidate will oversee microbiological testing and quality insurance processes within the laboratory or manufacturing environment and maintain the integrity of microbiological testing procedures. He or she will perform the following duties as well:

 DUTIES/RESPONSIBILITIES:

MANAGEMENT & LEADERSHIP

• Manage Quality Control laboratories, microbiology, Stability Studies, and Environmental Monitoring.
• Oversee a team of QC officers, including microbiologists and laboratory technicians in the QC microbiology laboratory, ensuring proper laboratory operations, quality control, and microbial contamination testing.
• Coordinate and manage relationships with other manufacturing departments such as production and warehouse, ensuring timely delivery of quality products in line with Quality Control standards and company goals/timelines.
• Ensure team compliance with all policies, departmental DOs and DON’Ts, procedures, and site/company regulations, enforcing GLP and US FDA 21CFR Part 11 adherence in all work areas.
• Set clear vision by aligning goals and objectives with site strategies, managing team members’ performance.
• Exhibit accountability and responsibility for areas or processes to affect change, lead efforts, and complete projects.
• Provide leadership for employee relations through effective communication, coaching, training, and development, while eliminating roadblocks to enable team progress.
• Plan and schedule bench work to optimize efficiency, productivity, and quality compliance.
• Ensure timely generation and issuance of test results and certificates of analysis (CoAs) to satisfy customer and dependent department needs.
• Evaluate laboratory records and ensure they are signed by the responsible person before submission to the quality manager.
• Provide exceptional internal and external customer service while challenging established procedures and systems with proven scientific innovations and literature references.
• Verify, review, and adjust controlled documents as necessary for the area of responsibility.
• Respond to customer and dependent department requirements, identifying and recording scope changes that may impact the department or company.
• Lead and chair teleconferences with clients/dependent departments to discuss relevant project results or additional requirements.
• Actively participate in and, when authorized, lead departmental and operations meetings related to quality control and assurance.
• Ensure job-specific responsibilities are assigned and carried out in accordance with the company’s core competency framework.
• Ensure the availability of appropriate laboratory resources, including consumables and equipment, properly utilized and always available to support daily operations.
• Provide technical recommendations for evaluating process data, troubleshooting, root cause analysis, and strategic recommendations for process improvements.
• Approve and monitor any contract testing laboratory for compliance and test results.

Planning, procedure, development & quality assurance

• Develop and implement departmental operating policies and procedures, ensuring ongoing development/modification of the quality control program and operational consistency in compliance with regulatory agencies.
• Align departmental goals with short- and long-term plans for accomplishment of company objectives.
• Ensure compliance with regulatory agencies and appropriate licensing for service areas and personnel.
• Maintain awareness of changing regulatory requirements and ensure laboratory policies and procedure manuals are up to date, well-organized, and accessible.
• Develop and implement systems for evaluating, revising, and communicating policies and procedures.
• Establish and monitor a comprehensive and effective quality control, preventive maintenance, safety program, data and materials management, and quality of service.
• Ensure appropriate analytical method development and process validations/qualifications are completed, with non-compendial methods validated and documented.
• Ensure all testing is conducted according to established procedures.
• Promote an engagement and compliance culture within the department.
• Review and approve specifications, sampling instructions, test methods, and other QC procedures before final approval from the quality manager.
• Assist in developing training programs and matrices to improve the technical capabilities and quality practices of staff.
• Ensure operational activities are controlled by approved SOPs or appropriate documentation for output consistency and laboratory quality assurance.
• Demonstrate an excellent understanding of internal procedures, industry regulatory standards, and technical expertise in microbiology.
• Stay informed of advancements in technology and contribute to implementing best practices.
• Ensure operational compliance with FDA and international regulatory agencies (i.e., FDA, EU, ISO, USP, NRC, etc.).
• Approve specifications, sampling instructions, test methods, procedures, and other QC procedures.
• Ensure testing equipment, materials, and procedures are calibrated, qualified, and validated with appropriate documentation on file.
• Ensure only validated or verified methods are used in the microbiology laboratory.
• Verify all test results and ensure retesting is approved before reporting and transferring to CoA for filing.

Staff performance appraisals & continuous quality improvement

• Actively promote an engagement and compliance culture within the department.
• Set clear vision, ensuring goals and objectives align with site strategies and manage team member performance.
• Measure and communicate progress against individual, team, and site goals/KPIs and engage officers on their performance appraisals.
• Recognize and reward performance.
• Build and maintain a laboratory quality assurance system to ensure confidence in microbial analytical results.
• Educate and provide feedback to the team regarding the business and financial impact of decisions/actions.
• Hold team meetings to discuss performance, provide updates, and track progress.
• Lead team in continuous improvement activities in the microbiology laboratory.

Communication, information systems &decision support

• Ensure accountability, transparency, and effective communication cross-functionally and within the team.
• Assist in maintaining, developing, and utilizing laboratory information systems (LIS) to optimize work quality and efficiency.
• Utilize computer-based methods to organize, analyse, and present data supporting decisions and objectives.
• Ensure accountability, transparency, and effective communication cross-functionally and within the team.
• Communicate within the department to ensure timely and accurate forwarding of relevant information and provide regular updates to the line manager.
• Write accurate and concise reports on duties and project status.
• Supply exceptional internal and external customer service and track progress against individual, team, and site goals/KPIs.
• Ensure laboratory records are evaluated and signed by authorized personnel before being sent to the QA department.

Time utilization

• Prioritize and coordinate responsibilities to ensure smooth laboratory operations, adjusting to fluctuating needs.
• Coordinate work to achieve efficiency and quality patient care.
• Ensure on-time completion of investigations and corrective action items assigned to the area.
• Adjust priorities as needed to meet project timelines.
• Complete all scientific project work to the required standard, within budget, and on schedule.

Report & documentation

• Prepare reports and oversee departmental documentation according to GLP, GMP, and SOP.
• Review and revise written documentation regularly to ensure compliance with laboratory standards and regulations.
• Prepare statistical data for departmental operations to submit to the quality manager.
• Assist in preparing the department’s annual report in line with established guidelines.
• Lead or support investigations.
• Approve and monitor contract testing laboratories for compliance and test results.
• Ensure recorded data is accurate, legible, and properly documented.

Cost containment

• Participate in cost control activities and maintain awareness of cost impacts from decisions and actions.
• Evaluate practices and identify areas for cost savings, rescheduling staff to minimize overtime.
• Help determine the most cost-effective materials and instrumentation for laboratory operations with the quality manager.
• Provide the quality manager with information necessary for the annual budget.
• Ensure scientific project work meets the required standards, within budget and timelines.
• Contribute to lab organization, improving efficiencies, and reducing costs.
• Identify opportunities to reduce risk, poor-quality costs, and improve service.

Learning and development

• Ensure all necessary training is received and documented before undertaking duties.
• Directly supervise first-line supervisors and oversee staff supervision.
• Evaluate and document staff performance, provide counselling as necessary, and participate in hiring recommendations.
• Communicate responsibilities and performance standards to employees, offering coaching for improvement.
• Discipline staff, when necessary, in accordance with company policies.
• Support staff development through training and mentoring, addressing skill gaps and improving technical capabilities.
• Ensure all training is recorded and up to date.
• Assign responsibilities, monitor staffing, and approve overtime as needed.
• Communicate assignment objectives clearly to staff, ensuring feedback and understanding.
• Solicit feedback from employees to ensure the assignment is understood.

Health, safety & cleanliness

• Understand and follow the company’s Health & Safety Policy, reporting any accidents or unsafe conditions.
• Enforce adherence to laboratory and departmental DOs and DON’Ts across all sites.
• Ensure proper maintenance, cleanliness, and organization in the department, adhering to safety procedures.

Reviews and investigations

• Investigate OOS, OOT, OOP, and OOE results and inform the appropriate staff according to procedures.
• Lead or support all laboratory investigations.
• Support deviation investigations and CAPA implementation for manufacturing issues.
• Review and approve area quality and safety exceptions and investigation reports.
• Ensure on-time completion of investigations and corrective actions.
• Communicate and investigate deviations from GMP procedures promptly.
• Ensure reviews of controlled documents are done on schedule, initiating change controls when necessary.

EDUCATION/EXPERIENCE

• A minimum of a Degree in General Microbiology/pharmaceutical Microbiology or equivalent experience.
• A minimum of 2-5 years of relevant working experience in laboratory role.
• Proficiency in office management software (Google workspace, office 365).

 REQUIREMENTS

• Excellent interpersonal and communication skills.
• Knowledge of multiple laboratory techniques and ability to troubleshoot.
• Must have experience in a GMP/GLP environment.
• Must be able to multitask and prioritize tasks in a fast-paced environment.
• Excellent organizational skills with ability to organise and plan work both independently and for tea

• Must pay attention to details and be proactive and Innovative with good initiate drive and result oriented.

• Must be strict, firm and fair in dealing with people.

• Must be honest with high sense of integrity.
• Must be diligent with High sense of urgency and responsibility.

• Must be a good team player and have a problem-solving skill.

• Strong high capability of critical analysis.

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