Muhammad Fais Haron Email & Phone Number

Malaysia

• Process engineering relating to the design, layout, URS and operation of process equipment and utilities systems in pharmaceutical or F&B industries.• Definition of process and utilities systems and equipment required to achieve the customer’s objectives.• Develops URS, process flow diagrams, P&IDs, equipment lists, calculations for process and utilities systems and equipment.• Communicate and coordinate with other disciplines.• Compliance with and actively contribute to the continuous improvement to the Quality Management System and Company Values.

Malaysia

• Support / lead the design and specification of cGMP equipment, processes and utilities for biopharma projects (brownfield and greenfield).• Liaise with vendor during commissioning for completing equipment qualification (FAT, IQ, SAT, OQ)• Collaborate with cross functional team as per project needs.• Support production operation for investigation of equipment related deviations (using Fish Bone diagram/Why-why question).• Supporting production for non-conformity and implementation of corrective/preventive actions in specific areas of operation.

Malaysia

• Support in facility fit assessment (FFA) for the new product introduction and process changes.• Create and review project documentation (URS, DQ, FRS/FS) in order to ensure alignment with (GEP) ISPE and CQV requirements.• Identify the constraints and debottlenecking of the manufacturing section by identifying the potential bottleneck.• Support continuous process and quality improvements in Production operation.• Standardize and improve process efficiency for upstream and downstream (design engineering support for manufacturing scale-up and implementation).• Work across organizational for gathering technical and quality inputs related to projects and production operations.

Nusajaya, Johor

• Assist with production planning schedules for related unit operations.• Proficient in downstream bio-manufacturing of drug substance recombinant Human Insulin & Insulin analogues (Aspart, Glargine and Detemir)• Update related documents through Change management panels, due to process improvement or resolve deviations and CAPAs based on ISO 9001.• Ensure the instructions relating to production operations are strictly followed and perform process with the requirements of cGMP and GDP.• Mentored new hires on SOPs, EOPs and BMRs which resulted zero process deviation.• Coordinate with Maintenance & Instrumentation department for equipment maintenance and calibration in order to attain smooth production schedule.• Team Lead in establishing dirty hold time (DHT), clean hold time (CHT) and process hold time (PHT) according to USFDA and PIC/S guidelines.• Review of batch manufacturing record and other related documents to monitor the compliance with the requirements of cGMP and GDP.• Ensuring effective implementation of EHS management system according to ISO 45001.

• Experience processes such as cell separation, pH adjustment, chromatography, crystallization, hydrolysis, autoclave, freeze drying, Cleaning in process (CIP), Sterilization in process (SIP).• Team Lead for Process Validation (PV) and Cleaning Validation (CV) for newly introduced product, area and equipment according to USFDA and PIC/S guidelines.• Ensure the availability and preparation of BMRs, CKLs, EOPs, SOPs and any related documents.

Bandar Enstek, Negeri Sembilan

• Handled process such as centrifugation, hydrolysis and crystallization for every batch (Reb-A, Reb-D and Alpha) of Stevia (Artificial sweetner)• Monitored all process and completed documentations such as shift reports to handover to the next shift• Comply with EHS policies and procedures

Malaysia