We are hiring for IPQA Officer in leading Medical Devices Manufacturing Company for Aegis Lifesciences private Limited at Moraiya, Near Ahmedabad, Gujarat

Company Name: Aegis Lifesciences private Limited

Department & Designation: IPQA Officer

Company Profile: Aegis offers products in more than 80 countries, including the most quality-conscious markets like Europe, USA, UK (NHS), Latin & Central America, CIS including Russia, Middle East, Africa, and Southeast Asia regions. Aegis also enjoys the certification as ISO:13485, MDSAP and the GMP standards of many countries. Aegis facility is registered with US FDA. Aegis Lifesciences has gained international certificates of CE (Class III medical devices), MDSAP & ISO: 13485 Quality Assurance System from DNV, Norway.

Company Website: https://aegis-lifesciences.com/

Location: Moraiya, Near Ahmedabad, Gujarat

Key responsibilities/ accountabilities:

- Recommend improvement measures to the production process to ensure quality control/assurance standards are met
- Ensure compliance with internal SOPs on shop floor
- Guide the production team about the quality control/assurance issues to enhance the quality of the product
- Monitor the production/packing phase at various levels
- Ensure cleaning and sanitization activities and environmental conditions in the controlled environment area
- Check the cleaning of garments and all hygienic activities
- Overview for clean room behavior and aseptic activity
- Responsible for quality verification of raw material and packing material/incoming material inspection
- Review, monitor and update nonconformity and deviation observed during daily in process activity




- Preparation of monthly rejection analysis report and submit it to reporting manager/plant head.
- Responsible for overall quality approve for in process stage from raw material to finish good department.
- Review the completeness of BMR/BPR and Records along with batch completion at every stage till archival of documentation.
- Review of calibration of instruments/equipments and validation of process
- Other responsibilities allotted by Quality Head or immediate reporting authority as and when required
- Sample Tracing and release/ reject procedure for RM, PM, In-process, semi-finished and finished product samples
- Reject all RM/PM/IP/FG fail to meet quality expectations and report the issue to the concerned department at the earliest
- Documentation control, Resolve quality-related issues in a timely manner
- Measure product dimensions, examine functionality, and compare the final product to the specifications
- Provide line-clearance at manufacturing and packing steps

Profile

- Ethical behavior and high level of integrity
- coordinate with the quality assurance group to include incoming inspection and other quality assurance processes
- Good teamwork, independent and committed to works across functional department
- Possess good negotiation and dispute resolution skills
- Demonstrated experience operating in a regulated setting
- Ability to write reports and quality procedures
- Excellent English communication skills, both spoken and written
- Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities

📌 Ipqa Officer (Sanand)
🏢 Aegis Lifesciences
📍 Sanand