about tech qualitas
tech qualitas is a quality-driven service provider focused on serving the pharmaceutical, biotech, medical device, and cro companies in following areas/domains:
• computer system validation
• it/qa services
• gdpr, hipaa compliance
• spreadsheet validation
• auditing services (third party gmp audits, internal audit management program, vendor and supplier management program, response to audit observations)
• compliant & secure software development life cycle
• sterilization process validation (gamma sterilization as per iso , eo sterilization as per iso , steam sterilization as per iso /who pda technical report series etc.)
• consultancy for pharmaceutical microbiology and contamination control (facility walkthrough and assessment, utilities assessment, clean rooms/hvac validation and routine controls, cleaning validation, sterility, bioburden, endotoxin, disinfectant validation, media fill validations, water analysis as per usp chapters)
job title
engineer/lead engineer – gxp systems at gmp sites
your job responsibilities
as an engineering lead, you will be responsible for overall it administration of gxp systems including
• user account management on daily basis – creation, removal, periodic review
• daily/monthly/yearly backup, restoration and archival of all gxp systems (instruments, ipcs, hmis, servers and application)
• installation of application on clients
• provide support as an administrator to application/system vendors
• during qualification of new application/instruments, provide support as an executor to service engineer & qc team
• applying security group on local drive of computer system for restricting access & deletion of data
• documentation maintenance such as active users list, backup logs, labelling of backup tape media and maintaining the log of media with retention data etc.
• prepare monthly/annual preventive maintenance planner for computers, servers, ups, etc.
• administration of qc and production domain