Manager - Microbiology

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Job Summary/Main Purpose

The QC Microbiology Laboratory Manager role at Julphar HQ in RAK is a leadership position responsible for overseeing quality control processes to ensure compliance with regulatory standards and GMP/GLP. This role involves managing laboratory operations, regulatory compliance, and cross-functional collaboration to maintain product quality and safety. The manager directs chemical and microbial laboratories, ensuring testing meets approved specifications and regulatory compliance, while managing ongoing stability and commercial programs. Responsibilities include reviewing SOPs, approving protocols and reports, and overseeing investigations and corrective actions, releasing/rejecting packaging, raw materials, finished product and stability. The role requires adherence to cGMP practices, data integrity implementation, updating procedures per regulatory requirements, managing quality management systems including change controls and deviations, and participating in internal and external audits.

Key Responsibilities

• Manage, plan and direct the Quality Control Microbial laboratories to ensure lab testing provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, GMP and safety regulation.
• To ensure the quality of laboratory is compliant with the approved specifications and GMP/GLP.
• Review testing for sterile samples (Sterility, LBPC, and BET) and related documentation over all microbiology labs.
• Review testing for non-sterile samples (MLT & bioburden) and related documentation over all microbiology labs.
• Review water testing, releasing and related documentation.
• Review microbiology lab supporting activity and related documents.
• Review microbiology assay & culture testing (Maintaining, sub-culturing, GPT and Identification) and related documents.
• Results approval, create the reservations and notifications through SAP system.
• Planning and supervise the day-to-day environmental monitoring activities in Microbiology labs and with coordination of analyst.
• Review risk assessments for Microbiology labs and Production plant.
• Ensure all Microbiologists are trained and qualified to perform tasks as per the approved procedure.
• Involve in Internal and External Audits.
• Complete corrective and preventive actions assigned by investigations or audit observations.
• Ensure to maintain online compliance and documentation in all assigned works.
• Follow safety precautions and good laboratory practices in the working area.
• Follow data integrity and Good Documentation Practices.
• Review SOPs, protocols and microbiology Qualification / validation documents.
• Review validation study & Qualification activity.
• Handling of deviations/OOS/OOL/excursions and appropriate closure.
• Apart from above, the works assigned by the Head of the department/Designee.
• Ensure team adherence to EMS and HSE requirements through monitoring, training, and guidance.
• Lead incident investigation, root cause analysis, and implementation of corrective and preventive actions.
• Drive departmental initiatives for environmental performance improvement and HSE culture.
• Execute and approve all laboratory investigations.
• Supporting the cross functional departments to achieve the goals / targets of the company.
• Handling of Quality management system like Change controls, Deviations, CAPAs, Self-inspection actions through Ample logic system.
• To approve all Microbiological analysis reports and analytical batch records.
• To prepare and involve in Budget requirements of QC.
• Following the cGMP practices.
• Store / Inventory Management
  
  

• High in collaboration, people management & leadership skills, responsible for directing multiple departments and stakeholders.
• In terms of competency, highly result oriented with strong sense of accountability & ownership.
• Having an analytical mind with ability to think diversely and understand the big picture of the organization and its core strategies to transform the Quality culture of Julphar.
• Strong communication, interpersonal, presentation and project management skills required.
• A solution centric mind you understand issues and solve them within a stipulated time frame with possession decision making skill for smooth functioning.
• Demonstrated experience in providing critical input to senior and corporate management.
• Excellent team building, and leadership skills.
• High on Accountability & Ownership
• In terms of Competency, you are highly oriented with a strong sense of accountability & ownership,
• Excellent communication, interpersonal and presentation skills.
• Technical Competencies: In-depth knowledge of the industrys standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan
• Strong eye for details, having expertise to understand, review and implement the compliance inputs from Quality point of view.
• In-depth knowledge of the industry’s standards and regulations guidelines, excellent
• Problem Solving and high agility on taking right scientific decisions.