Executive 1

Job Description

Designation: Executive, Biopharmaceutical DevelopmentJob Location: Bengaluru, IndiaReporting to: ResearchScientist, Biopharmaceutical DevelopmentJob Grade: 9Operating Unit : BiopharmaceuticalsDepartment: Biopharmaceutical DevelopmentThe CompanySyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.The RoleDevelopment data and document management system (D3S) representative for Biopharmaceutical development (BPD) department. Responsible for improving the documentation and monitoring quality compliance activities by acting as a bridge between BPD and Development Quality Assurance (DQA) department.Key Result AreasRole-specific:
• Safety, Quality, Integrity & Compliance: Establish operational standards, implement, monitor, audit and train the BPD functions.
• Build integrated relationships with cross functional teams to bridge the gaps between BPD & other support teams. Create and oversee a collaborative framework between BPD, IT, EAM and Quality.
• Actively participate in Good documentation practices (GDP), Documentation and Quality initiatives for BPD.
• Responsible for improving and monitoring quality of documents at Biopharmaceutical development (BPD) department.
• Performing gap assessments related to system or functions identified for improvement.
• Review and/or approval of protocols, reports, MBPRs and executed BPRs.
• Issuance of protocol and report numbers.
• Issuance of lab notebooks and archival of records such as logbooks, lab note books, protocols, reports, ODS, BPRs.
• Preparation and review of D3S procedures and other SOPs as per requirement.
• Participating in investigations related to noncompliance and proposing effective corrective and preventive actions.
• Act as eQMS initiator and log appropriate QMS as required for various departments in BPD
• Act as EDMS coordinator for the department
• Issuance and maintenance of training binders.
• Conducting compliance related trainings at BPD.
Education and ExperienceEducationMaster s in BiotechnologyExperience3-6 yearsFunctional or Technical skills Required
• Responsible for following the safety standards at Syngene International Ltd.
• Participation in Syngene wide compliance initiatives.
• Performing any other activities assigned by the department head.
Equal Opportunity EmployerIt is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.Please visit us at https://syngeneintl.com/ to know more about us and what we do.,

Keyskills :
data managementclearingquality assurancetechnical skillsretailmisfinacle