Job title: Sr Specialist Technical Document
Company: Teva Pharma
Job description: Company Info Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with co
Company Info Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth! Job Description Maintenance of Master Documents viz. SOP’s, Batch records, AWS’s, STP’s, MTP’s etc. Issuance and distribution of controlled documents to various departments as per the requirement. Retrieval of obsolete and superseded documents. Maintenance of executed documents. Preparation of documentation related SOP’s. Maintenance and updation of Change Control, Temporary change, Event, LIR logs Review and approval of Batch Manufacturing records, Batch Packing records, Batch analytical records (Inprocess and Finished Product), SOP, Protocols and Specification. Performing Deviation related Investigation and CAPA Implementation. Compilation of data required for Annual Product Review. Maintenance of Documentation Cell. Immediate reporting of non-compliance / Observation in Documentation to supervisor. Issuance of documents related to RA Submissions Job Description contd… Data integrity compliance SAP R/3 System Handling Responsible for management of trackwise system implemented for handling of quality management systems Responsible for management of Glorya EDMS system implemented for preparation ,implementation ,distribution ,review and Storage of SOP’s and addendum Qualification Facilities, Utilities, Equipment, Critical systems, Computer-related systems (IT) and lab equipment’s. Review of TCCs/CAPAs of Facilities, Utilities, Equipment, Critical system and Computer-related systems (IT). Review of maintenance work order. Monitoring of Calibration and Preventive Maintenance program for manufacturing equipment’s and Laboratory equipment has and instruments are conducted as per approved schedule Review of Layouts related to Facility Preparation, execution, review and approval of study protocols Participate in all new projects implementation relating to equipment, critical systems and information technology Qualifications MSc/Bpharm/DPharm with 4 to 5 years’ experience in Documentation Function Quality Sub Function Documentation Life Cycle Already Working @TEVA If you are a current Teva employee, please apply using the internal career site available on ‘Employee Central’. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva’s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Expected salary:
Location: India
Job date: Thu, 30 Jun 2022 22:19:33 GMT
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