13 Sterility Assurance Jobs

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assuran...

Role & responsibilities - Ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at the microbiology laboratory. - Participate in the sterile quality management review periodically - Ensure the microbial monitoring program in the site is adequate Environmental Monitoring (EM) Personnel Monitoring Media Fill Simulations (Process Simulations) - Periodic review and routine check of classified areas in microbiology lab areas - Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product - Participate in the...

Role & responsibilities - Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site - Conduct sterile quality management review periodically - Periodic review and routine check of classified areas like manufacturing, Microbiology and utility areas - Preparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalification - Ensuring SOP adherence to clean room facility / utilities/ equipment / Personnel qualifications whichever has a potential to impact the Sterility of the product. - Review validation / protocol studies which has potential to d...

Job Role : Sr.Manager / DGM - Sterility Assurance Location : Halol - Vadodara Job Summary : In this Job role we are looking for Sterility Assurance, QMS elements for Sterile manufacturing Units with experience in Regulatory Audit Queries. Responsibilities : Owning of Aseptic process simulation program of the site including protocol / operators and intervention qualification program / Trending and Aseptic process simulation summary report. Own and continually develop the Site's Contamination Control Strategy. Ensure Contamination control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Lead Sterility Assurance committee for the site...

**Role Overview:** If you have the talent and zeal, an opportunity awaits you to join our Greenfield Injectable manufacturing plant at Ahmedabad in various roles such as Production, Engineering, Quality Assurance, and Quality Control. **Key Responsibilities:** - **Production: Shift In charge** - Supervising Injectable production with a B. Pharm/M.Pharm qualification and 3 to 10 years of experience. - **Production: Operator/Tech. Associate** - Operating in Injectable production with an I.T.I./ Diploma qualification and 2 to 8 years of experience. - **Engineering: Shift Incharge** - Handling Instrumentation, Plant maintenance, Engineering QMS for Injectable Manufacturing Plant with a B.E./B.Te...

Company Description AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D,...

Role Overview: As a Senior Manager / DGM - Sterility Assurance at our Halol - Vadodara location, you will be responsible for overseeing the Sterility Assurance and QMS elements for Sterile manufacturing Units. Your role will involve handling Regulatory Audit Queries and ensuring the implementation of contamination control strategies in compliance with regulatory standards. Key Responsibilities: - Own the Aseptic process simulation program of the site, including protocol development, operators training, intervention qualification program, and Trending analysis. - Develop and enhance the Sites Contamination Control Strategy to ensure robustness and continuous improvement. - Lead the Sterility ...

Role Overview: As a Manager in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac), your role will be critical in handling in-process Quality Assurance functions. You will ensure that defined and approved IPQA checks are followed and documented during Dispensing, Manufacturing, filling, capping, and Packing stages. Your responsibilities will include ensuring compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing. Additionally, you will review Smoke study protocol, report, and Video recording, and participate in regulatory audits. Key Responsibilities: - Handle in-process Quality Assurance functions by ensu...

Role & responsibilities To take care of Sterility Assurance Involved and well aware about Aseptic processing area requirement, personal qualification, Aseptic practices and concept Daily round at shopfloor for review and gap assessment. To do transfer Sterility assurance trending Aseptic area cleaning requirement and practices, on spot cleaning checking CCIT Preferred candidate profile Exposure in PFS, Cartridge, Vial filling line process Knowledge about sterility assurance concept Knowledge of Contamination control strategy and risk assessment Aware of Environment Monitoring concept Acquainted with media fill concept, BMR, Regulatory requirement Acquainted and involved in smoke study concep...

May support in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ). Be the point of contact for suppliers/development engineers for new process development, quality issues and process improvements for assigned projects. Participate in the development and improvement of the manufacturing processes for existing and new products. Support product transfers to other plants/facilities. Review/approve nonconforming material and system documentation. Review/approve product and process change control documentation and specifications. Actively participate on teams to support new product development activities. Support design verification ...

Job Information Job Opening ID ZR_1781_JOB Date Opened 24/03/2023 Industry Technology Job Type Work Experience 5-8 years Job Title Sr. Engineer (Microbiologist) City Gurgaon Province Haryana Country India Postal Code 201303 Number of Positions 1 May support in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ). Be the point of contact for suppliers/development engineers for new process development, quality issues and process improvements for assigned projects. Participate in the development and improvement of the manufacturing processes for existing and new products. Support product transfers to other plants/facilities. Review/...

May support in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ). Be the point of contact for suppliers/development engineers for new process development, quality issues and process improvements for assigned projects. Participate in the development and improvement of the manufacturing processes for existing and new products. Support product transfers to other plants/facilities. Review/approve nonconforming material and system documentation. Review/approve product and process change control documentation and specifications. Actively participate on teams to support new product development activities. Support design verification ...

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assuran...