Open Vacancies At Tabuk Pharmaceuticals
1-Senior QA Officer
Location: Dammam, Saudi Arabia
Job Description
Quality inspection of pharmaceutical manufacturing and documents.Quality inspection of pharmaceutical manufacturing and documents.
Implement approved departmental Standard Operating Procedures (SOPs) for all production activities.
Provide line clearance for production activities within the designated production areas.
Sample finished products, intermediates, in-process materials, stability samples, cleaning validation samples, verification samples, and reserve samples as per defined protocols.
Approve packaging materials specimens to be attached with Packaging Order Instructions (POIs).
Check manufacturing and packaging POIs in the production area to ensure compliance.
Inspect finished goods and authorize their release for dispatch or recommend rejection as per standard procedures.
Affix Release and Rejection labels provided by QC for product batches at various stages of manufacturing.
Highlight quality-related problems for thorough investigation and resolution.
Ensure compliance with documentation system requirements throughout production activities.
Manage non-conforming products by initiating actions such as rejection for investigation, rejection for destruction, or addressing out-of-specification issues.
Conduct cGMP checks in the production department to ensure adherence to Good Manufacturing Practices.
Conduct training on related QA SOPs for staff.
Arrange technical training courses to enhance professional skills.
Identify specific training needs based on job titles as listed in the training needs assessment
Job Requirements
Bachelor Degree in Pharmacy, Science, Medicine or Chemistry
Years Of Experience : 2 – 3 Years
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2- Sr. Qc Officer
Location: Saudi Arabia
Job Description
Preparation and review of SOPs.
Preparation and execution of non-routine study protocols.
Preparation of purchase requisitions and job orders.
Stock maintenance for culture media and miscellaneous items in the laboratory.
To register the receipt of samples in Microbiology laboratory.
Verification of balances and PH meter.
Calibration of instruments in the laboratory.
Microbial Limit testing of Raw Materials, finished goods and water.
Sterility testing, BET and LBP testing of sterile products.
Maintenance of cultures and use of cultures as per the laid down procedures.
Preparation and sterilization of culture media.
Perform operators, qualification for related personnel working in sterile area.
Growth promotion and sterility testing of culture media.
Preparation and testing of disinfectants.
Environmental monitoring in production areas and Microbiology laboratory.
Daily Monitoring of microbiology laboratory.
Decontamination of the used media and contaminated items.
Analysis of cleaning validation swabs.
Perform Microbial assays and antimicrobial effectiveness testing.
Testing of compressed gases.
To dispose samples after analysis.
To follow approved specification and test procedures for analysis.
Preparation of trend charts for Environmental monitoring and water testing.
To carry out method validations of sterility, BET and MLT.
To follow approved departmental SOPs.
To record analytical results in register and reconfirm calculations
Job Requirements
Educational qualification: Bachelor of life science
Experience : 5 to 7 Years
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3-Production Officer
Job Description
Prepare material requisition for routine dispensing of batches.
Monitor the filling process & calibrate the machine if needed.
Oversee setting up machines (calibration, cleaning etc.) to start a production cycle.
Distribute & assign duties for operators & workers as per area and machine.
Monitor the area temperature, relative humidity and differential pressure as per IPC.
Check equipment availability and operational status to ensure production processes are carried out.
Inspect machines & work area regularly to ensure safety, maintenance & cleanliness.
Check work documents for POI & logbooks.
Assist in diagnosing & attend the shop floor troubleshooting.
Check output to spot any machine-related mistakes or flaws.
Monitor the production plan on a time line and FIFO system.
Conduct investigation for production nonconformance according to approved SOP.
Inspect equipment & machines to identify any replacements, malfunctions and repairs.
Label receipt of each compound subsequently activating it in the machine.
Monitor & operate filling machine through the part assembly machine & verify as per IPC process.
Ensure product quality by performing in-process checks, complying with cGMP.
Coordinate & follow up with production supervisor for daily work processes.
Communicate quality and other non-compliance issues to supervisor in a timely manner.
Monitor the whole process of manufacturing & packaging on a regular basis.
Measure performances based on work shifts.
Communicate with production planner & other departments to determine the priority for production activities.
Keep records of approved and defective units or final product.
Maintain daily production sheets and time sheets for team.
Monitor manual packaging output & update output sheet accordingly.
Oversee cleaning at the changing rooms along with entry & exit procedure for each person.
Monitor daily uniforms, shoes, ID cards etc. for all manpower.
Ensure adherence to concerned SOP & cGMP guidelines at the time of operating machines.
Ensure adherence to concerned Quality standards & safety guidelines.
Identify and report unsafe operations to Supervisor immediately.
Organize & maintain production plan in SAP.
Maintain financial data related to production in SAP.
Prepare periodic reports with respect to the activities and achievements according to the need.
Manage employee affaires including: attendance, leaves, vacations, performance appraisal etc. in coordination with HR & Admin dept. according to the company policies and procedures.
Identify training needs in staff capabilities, knowledge & skills and come up with development plan followed by evaluation.
Ensure confidentiality of all documents and information related to work.
Ensure strict implementation of policies and guidelines.
Perform any other duties related to the job according to the business needs
Job Requirements
GMP (Goods Manufacturing Practices)
Team Building
SAP
Leadership Skills
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4-Validation Supervisor
Job Description
Bachelor degree in engineering/science or relevant
Very good in English reading , writing and communication.
Experienced in Microsoft Office (word, Excel , power point)
Strong communication skills with different level and departments.
Professional in Creating and Review Validation protocols, reports and dashboards
Strong knowledge of manufacturing process (for sterile and non-sterile manufacturing)
High level of leadership skills
Strong understanding of regulatory requirement related to validation. (sFDA, EU. WHO )
Familiar with GxP compliance.
Familiar with Calibration and Qualification software
Self-learning and team motivator.
Professional for multi tasks follow-up.
Job Requirements
Manufacturing equipment qualifications (IQ,OQ, PQ)
HVAC qualification and area Classification (ACR,DP,PAO testing, Viable testing ..etc.)
Qualification and Calibration Risk Assessment
Aseptic Process Simulation
Thermal Mapping (sterilizers, storage area and controlled chambers..etc)
Process Validation
Cleaning Validation
Monitoring, recording and logging Instruments Calibration
Preferable to have experience in:
Analytical instrument calibration and qualification experience
CSV