Senior QA Officer - Microbiologist
scitra -
6th of October, GizaPosted 4 years ago78Applicants for1 open position
- 55Viewed
- 14In Consideration
- 21Not Selected
Job Details
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Job Description
Financial
- Commitment to the budget and expenses specified for the department
Customer
- 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 the quality of products are investigated and provided proper corrective and preventive actions.
Internal Process
- Microbiological & analytical testing of Bulk, Finished Product & Raw material.
- Test stability samples microbiologically and analytically as per the required schedule.
- Test Complaint / new source samples.
- Implement SOPs and protocols within the lab.
- Perform and maintain a record of equipment calibration/ Standardization and maintain the 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 the 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 with predefined procedures, and result reported on the agreed time.
- Ensure all stability testing of samples shall be completed timely as per the required schedule.
- 100% compliance of 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 the 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 daily tours to confirm an individual's 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 the 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.
- Switch off and secure unattended plants or equipment.
- Avoid improvised arrangements and suggest safe ways of eliminating hazards.
Job Requirements
- Graduate or post-graduate in Science/Pharmaceutical
- ISO Internal audit training/certification (Preferable but not essential)
- Communication skills
- Punctuality
- Achieving results
- Action Orientated
- Micro related knowledge and information that enabling him to perform the micro related activities
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