5 Qualification Testing Jobs

Role & responsibilities 1. Routine and Stability analysis of development batches. 2. Analytical support for development of new or existing APIs. 3.Analytical method development and validation of raw materials, intermediates, finished APIs, under close supervision of senior analyst. 4.Qualification, Calibration and maintenance of analytical instruments. 5.Perform Calibration of analytical instruments and online documentation as per GDP requirement. 6. Preparation / Review of test method specification, method development protocol, method development report and analytical reports. 7. Work as per Good Laboratory Practices (GLP). 8. Maintaining log books, column usage cards and calibration records. 9. Following safety in the laboratory premises by using personal protective equipment and guiding to the subordinates to follow safety norms.

BASIC SUMMARY: Responsible for technical support for Endosafe (including automated NEXUS system) and/or Celsis and their associated systems. Support customers on Endosafe® and/or Celsis™ instrument installation, qualifications and product validation. Provide on-site training, sample testing or troubleshooting for continued customer satisfaction of our clients. Manage activities to help meet revenue targets and goals for the business. ESSENTIAL DUTIES AND RESPONSIBILITIES: Understanding and application of one or more of the product lines under the Microbial portfolio (Endosafe® and/or Celsis™) Applies technical/scientific skills to develop existing accounts and compete for customers together with the Account Management team whether for products sales or services sales. Supports customer onboarding, provide customer training, qualify leads, perform test demonstrations and help close new business opportunities during customer start up and continued account management. Responsible for the initial training and validation/application development support for customers, ensuring full and continued utilization of Microbial Solutions products. Recommends or performs remedial actions to troubleshoot customer issues related to application, reagents and software for the assigned product line. Performs instrument qualification and installation for new customers Establishes regular interface and communication with the Account Management and Field Services team to relay shared goals and targets; develop co-strategies to achieve defined targets; and work cohesively as a team to provide excellence in service to clients Builds relationships with customers to influence the acceptance and use of Microbial portfolio Input, manage and monitor cases on Service Cloud or SFDC. Ensures activities of the Technical Services team are continuously compliant to ISO 9001, Company local & global SOPs and data integrity principles and requirements, where appropriate. General requirements Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements. Maintains appropriate records and documentation of activities to facilitate continuous compliance to ISO 9001, Company local & global SOPs and data integrity principles and requirements, where appropriate. Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements. Must be willing to travel domestically and internationally to customers’ sites Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements. Performs all other related duties as assigned. Preferred candidate profile QUALIFICATIONS: Education: Minimally M.Sc. or equivalent in Biology, Botany, Microbiology, Life Sciences, Biotechnology or any other related scientific discipline. Experience: 0-5 years of relevant industry experience, preferably involving customer-facing responsibilities. Understanding of Biology/Microbiology in the Pharma setting is an advantage An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Other: Must possess excellent communication and presentation skills. Proficient in the use of Microsoft Office applications

1)Good understanding in Environmental, EMI/EMC Qualification as per DO-160/MIL/IEC/EN standards 2)Experience in conducting successful environmental tests, and producing reports and technical data 3) Experience in writing Qual test reports, Procedure and Planning documents 4) Skilled in writing and defusing of MTRs 5) Good in American English writing and MS word formatting etc. 6) Highly skilled in operating and handling automated test stands and general lab equipments E.g.: Data loggers, oscilloscope, Power supplies, Signal analyzers etc. 7) Good understanding of vibration, shocks and experience in performing vibration test as well as post test data analysis . 8) Good skill in post test data analysis in excel and plotting different graphs to show test results for Qual test reports. 9) Evaluation of test data to establish correctness through reduction analysis and interpretation of instrumentation data 10)Knowledge about ABD0100 and Boeing Qualification standards will be added advantage

quality checks on raw materials, in-process, and finished product proper documentation as per GMP standard stability studies, sampling, and lab testing compliance with SOPs, regulatory, and safety guideline audits and assist in CAPA implementation

compliance with GMP and quality policie Approve RM/PM vendors and conduct regular quality audit validation, qualification, and batch release. GMP training $ support factory-wide implementation. Manage change control, deviation, and QMS execution.