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Job Description
- Liaise with clients and customers to deal with day to day QA and QC issues
- Support Suppliers in non-conformities cases via roots cause analysis and CAPA approval
- Support the customer complaint handling system to ensure that all complaints related to quality of product are investigated and provided proper corrective and preventive actions
- Microbiological & analytical testing of Bulk, Finished Product & Raw material.
- Test stability samples microbiologically and analytically as per required schedule.
- Test Complaint / new source samples.
- Implement SOPs and protocols within the lab.
- Perform and maintain record of equipment calibration/ Standardization and maintain record.
- Ensure Microbiological approved test method, monographs etc. available and easily accessible to perform related activities.
- Provide all microbiologically support.
- Manage and keep all Microbiological records, data logging, files as per good laboratory practices (GLP).
- Ensure that all consumables items, Glasswares, media, lab reagents etc. required to conduct microbiological testing are available all the time.
- Arrange all required Consumables, reagents, glassware and Stationary items for QC, ensure that sufficient stock is available all the time and maintain record.
- Any other task assigned by immediate manager / top management.
- Ensure no critical / major observation noted by customers and ISO Auditors.
- All microbiological and analytical sampling & testing shall be done 100% in compliance to predefined procedures, and result reported on agreed time.
- Ensure all stability testing of samples shall be completed timely as per required schedule.
- 100% compliance with all SOP’s and protocols in the lab.
- Ensure the water analysis for both raw and manufacturing water are within specs all the time
- Lead the cleaning and sanitization process and approve all relevant WI after proper validation
- Ensure the Hygiene manual is up to date and in line with customers’ requirements
- Provide the needed support to the chemical lab as determined by his manager
- Ensure the micro lab spent is in line with the allocated budget.
- Improve the level of micro and hygiene awareness in the plant by giving training to the staff and continuous follow up.
- Review and approve the batch release system on behalf of the quality manager when requested.
- Providing Support to Quality manager in decision making in terms of any case related to microbiology.
- Release, Hold or reject the product based on the level of compliance versus customer’s product quality standard.
- Conducting the daily tours to confirm individuals behaviors and personal hygiene.
- Follow up and do the required visits on time of the external micro lab to make sure that they are in line with the standard.
- Act as the system owners for both the change control and validation system .
- Providing support to other departments for all issues related to the quality of product.
- Owning the authority to stop the production in case of any micro risk that might impact the product.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with safety rules/procedures, regulations and codes of practice.
- If aware of any unsafe practice or condition, or if in any doubt about the safety of any situation, consult their supervisor.
- Obtain and use the correct tools/equipment for the work and not to use any that are unsafe or damaged. All tools, equipment and personal protective equipment must be stored in the approved place after use.
- Ensure that all safety equipment and personal protective clothing/equipment provided are used.
- Not to operate any plant or equipment unless authorized.
- To report any accident, near-miss, dangerous occurrence or dangerous condition to their line management.
- To switch off and secure unattended plant or equipment.
- To avoid improvised arrangements and suggest safe ways of eliminating hazards.
Job Requirements
- Degree in Microbiology or Pharmacy or Sciences
- 5 years of experience as a Microbiologist (essential).
- Ability to plan and execute experimental protocols.
- Excellent knowledge of electron microscopes, electronic equipment, chemical samples, and stains and weighing equipment.
- Highly skilled in microbiology techniques, methodology, equipment and supplies.
- In-depth knowledge of laboratory tests used in microbiology work.
- Proficient in methods and practices of microbiological analysis.
- Great ability to prepare research papers and technical reports.
- Analytical thinker with strong conceptual and research skills.
- Strong leader who displays accuracy and attention to detail.
- Strong IT and math skills.
- Excellent laboratory skills.
- Willingness to keep up-to-date with current information and research.
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