Dear All, We are hiring for the below position.
Quality Assurance -Executive
The In-Process Quality Assurance Executive will be responsible for ensuring that all products are manufactured and packaged in accordance with cGMP and other regulatory standards. The position will work closely with production teams to monitor and verify the quality of products throughout the manufacturing process.
Monitoring over the personnel competence according to their involvement within the
Quality System.Maintaining and improving the Quality System’s effectiveness as far as the compliance with the requirements of ISO 13485 Standard and other regulatory requirements are concened.
Identifying quality problems and promoting the appropriate corrections, corrective and preventive actions in order to solve or prevent them. Issue advisory notices and carry the process. Collaboraing with the Director/CEO to elaborate the planning, to follow up and to achieve quality objectives and to carry out internal audits planning.Meeting external audits requests. ” Handling of complaints and internal non-conformities.
” Responsible to control of Master documents and control the specification of
Manufacturing Formula, Filling, Labelling and ASsembly. ldentify Root cause of the problem and initiate corrective and preventive action,
Effectiveness assessment and closure (CA/PA), Issue advisory notices and carry the process.
. Planning of validation activities, implementation, generation of records and archival. . To calibrate, to verify and/or to adjust Measuring Devices and Standards or to manage their external calibration and/or preparation.
Control of Measurement and Monitoring Devices used to Control Products.
Preparing Technical Information for Product Registration.
Product Registration and Legal Affairs.
Registering/Licensing products. Updating Technical Reports to Authorities.
Desired Candidate Profile:
- Bachelor’s / Master’s degree in Chemistry, Biochemistry, Pharmacy, or related field.
- At least 2-5 years of experience in in-process quality assurance in the In Vitro diagnostics (IVD) or Biotech/life science industry.
- Strong knowledge of cGMP and other regulatory standards for in-process quality assurance.
- Excellent problem-solving, communication, and interpersonal skills.
- Ability to work independently and in a team environment.
- Experience in participating in investigations of deviations and non-conformances, and providing support for root cause analysis and CAPAs.
- Strong analytical and documentation skills.
- Experience in participating in internal and external audits and inspections.
Reach us on the below numbers
To apply for this job please visit in.indeed.com.