6 Sterility Assurance Jobs

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 ensuring compliance with defined IPQA checks during various stages of manufacturing - Ensure compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing - Review Smoke study protocol, report, and Video recording, and authorize final document approval in the absence of Head Quality Assurance - Participate in regulatory audits and ensure compliance - Review and approve Process validation, cleaning validation, aseptic process simulation protocol, reports, change control, deviation, incident reports, OOS, OOT, non-conformance, and CAPA in consultation with Head Quality Assurance Qualifications Required: - M. Pharm/B. Pharm qualification - 15 to 17 years of experience in the pharmaceutical industry - 03 years of experience at Zydus - Knowledge and experience in an injectable plant Please email your CV to isha.naik@zyduslife.com for consideration.,

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 concept, execution and review w.r.t sterility practices

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 and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria. Specific Job Skills: Must understand the fundamentals of at least one of the following sterilization techniquesgamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques. Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures. Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives. Experience with ISO 17025, Lab Quality Management System. Desired Profile EducationM.Sc. in Microbiology ExperienceMin 5 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.

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/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 and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria. Specific Job Skills: Must understand the fundamentals of at least one of the following sterilization techniquesgamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques. Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures. Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives. Experience with ISO 17025, Lab Quality Management System. Desired Profile EducationM.Sc. in Microbiology ExperienceMin 5 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience. check(event) ; career-website-detail-template-2 => apply(record.id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#2B39C2;border-color:#2B39C2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered=""> I'm interested

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 and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria. Specific Job Skills: Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques. Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures. Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives. Experience with ISO 17025, Lab Quality Management System. Desired Profile Education: M.Sc. in Microbiology Experience: Min 5 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.

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 assurance. Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the Lan and insure implementation within the department. Maintain thorough knowledge and understanding of regulatory requirements pertaining to microbiology and sterility assurance testing. Play a lead role in the review and approval for appropriate department SOPs, protocols, and data forms. Ensure equipment maintenance and calibration performed within the department meets the calibration/maintenance schedule. Take a lead role in validating new equipment or testing procedures. Regularly attend meetings and seminars to stay current with industry practice. . Required Skills Have good communication skills. Logical Thinking Organizing Required Qualification: - M.sc -Microbiology