Pune Biotech Officer Production Mammalian MH

Job description

Responsible for manufacturing operations related to upstream of Mammalian Manufacturing facility. Preparation and review of GMP documents like SOPs, BPRs, qualification and validation protocols, technology transfer documents and other process or facility related documents for media preparation and cell culture operations. Execution of disposable bioreactor, SS bioreactors and glass bioreactors operations as per written procedure. Execution of media fill inoculum transfer and subculture operations as per written procedure. Responsible for execution of media preparation, CIP and SIP of bioreactors, cell culture and cell banking operations as per written procedures. In-process recording of process parameters and In-process sample analysis for media preparation and cell culture operations. Maintenance of facility and equipment related to media preparation operations, cell culture operations and cell banking operations. Co-ordinate with QC, QA, Engineering, WH, MSAT and R&D departments. Execution of qualification activities related to equipment and process. Preparation of documents related to tech transfer and scale up of process. Participate in tech transfer and scale up of process. Preparation, execution & maintenance of SOP’s, BPRs, qualification documents and other facility related documents i.e. URS. Responsible for all production related SAP transaction. Plan and execute operations related to process characterization & process validation. Review of executed BPR’s and protocols, logbooks, annexures, checklist and other essential cGMP documents. Planning and facing of internal as well as external audits/visits as per business requirement. Deviation identification and investigation assistance for the facility related deviations Routine monitoring of facility and record maintenance e.g. temperature, humidity, differential pressure. To assist in facility validation in coordination with QA. Routine environmental monitoring, record maintenance and co-ordination with engineering and QC department for smooth facility maintenance. Overall housekeeping management. To assist in facility validation in coordination with QA. Any responsibility advised by the superior from time to time. To comply with the current & subsequent EHS management system, procedures, guideline, policy, practices, requirement and applicable legal compliances on site. Work Experience 0-2 year Education Masters in Biotechnology Others in Life Science or Pharmacy Competencies Apply now » Apply Now Start applying with LinkedIn Please wait... Find similar jobs: Multicare-Philippines, Lupin-India Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. Required Cookies Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off Advertising Cookies These cookies serve ads that are relevant to your interests. You may freely choose to accept or decline these cookies at any time. Note that certain functionality that these third parties make available may be impacted if you do not accept these cookies. Consent to all Advertising Cookies Advertising Cookies Provider Description Enabled LinkedIn LinkedIn is an employment-oriented social networking service. We use the Apply with LinkedIn feature to allow you to apply for jobs using your LinkedIn profile. Opting out of LinkedIn cookies will disable your ability to use Apply with LinkedIn. Cookie Policy Cookie Table Privacy Policy Terms and Conditions Consent to cookies from provider LinkedIn