Job Description

QA/QC PersonnelWork for a medical device company in Gandhinagar that manufactures Intraocular lenses for cataract surgeries.They are pledged to maintain consistency in product quality by implementing quality management systems to sell products across the globe. Their team is growing, and they are looking for Quality Assurance & Quality Control personnel to join their team.Job responsibilities:

• Responsible for generations rejection chart as per lot or lenses manufactured.
• Responsible for the quality assurance of the batches manufactured
• Responsible for identifying the training requirements of the manufacturing and maintenance personnel and imparting the required training.
• Responsible for technical review during new supplier registration and coordinating the inspection of purchased product.
• Control of quality records.
• Responsible for Calibration/Validation activity.
• Responsible for guiding the Q.C. personnel in attending to Q.C. related problem.
• Responsible for shelf life data study with the production manager.
• Responsible for Finish good & raw Material testing, monitoring and release.
• CE, ISO, FDA communication, data and document Verification & checking. Face audits.
• Responsible for batch release.
• Authorized to take necessary action to stop non-conforming products.
• Authorized for carrying out corrective and preventive actions.
• Authorized to investigate customer complaints and initiate Product Recall, if required
• Authorized for taking decisions pertaining to the machine maintenance

• Bachelor\xe2\x80\x99s Degree in science field with 5 + years of experience OR Master\xe2\x80\x99s Degree in science field with minimum 3 years of experience.
• Experience in pharmaceutical/biotechnology/medical device industries is preferable.
• Understanding of cGMP/ISO/CE guidelines and regulations.
• Experience in developing, reviewing and approving cGMP and ISO related documents (SOPs, protocols, reports, etc)

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