Job Description

JOB DESCRIPTION

Designation: Deputy Manager

Job Location: Bangalore

Department: Quality Assurance - GLP

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene\' s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose:

• To Ensure the compliance to Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP) and ICH GCP.

Key Responsibilities:

• Supporting QA head in staff planning by selecting, recruiting, orienting, and training employees
• Assist in leading the GLP QA team and providing periodic feedback
• Communicating the organisation values and objective to team staff
• Conducting training for GLP team
• Co-ordinating regulatory and sponsor audit
• Receipt and review of general documents/SOPs, MOA, Study Plans and Study Reports
• Preparation and /or review of SOPs and other documents related to QAU
• Maintain copies of approved Study Plans, MOA and general documents
• Review of Method of Analysis and Study plan
• Performing/scheduling study, facility and process-based inspections
• Perform audit of study raw data & study report
• Review of electronic data and audit trail for data generated in bioanalysis
• Review of computerized system documents with respect to OECD 17,21 CFR Part 11 and GAMP
• Assure that documentation, systems and equipment comply with meeting the requirements of ISO/IEC 17025:2017
• Review of electronic data and audit trail for data generated in bioanalysis
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Review of equipment calibration records, temperature monitoring records of freezers used during study of Archival of inspection reports
• Report the observations/findings of inspections to the respective auditee and management in a timely manner
• Review the data for quality meetings

Educational Qualification & Experience:

• Minimum Masters Degree M. Pharm / Masters of Science (Microbiology / Biotechnology/Biochemistry)
• Good speaking-listening-writing skills, attention to details, proactive self-starter
• Team management (hiring, training, job assignment)
• Experience in conducting training
• Experience in handling GLP inspections and other regulatory inspections
• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team
• Ability to work successfully in a dynamic, ambiguous environment
• Ability to meet tight deadlines and prioritize workloads
• Ability to develop new ideas and creative solutions
• Should be able to work in team and flexible for working in shifts

Technical/functional Skills:

• Knowledge on OECD GLP Principles, US FDA 21 CFR part 58, EPA 40 CFR part 160, 21 CFR part 11, EMEA, ANVISA, Bioanalytical Method development and Validation Guidance, GCLP Guidance, ICH-GCP Guidance
• Knowledge on application of GLP in computerised systems
• Fundamental knowledge on toxicology, mutagenicity, bioanalysis (large and small molecule), physical chemical testing, analytical & clinical chemistry studies
• Well versed in electronic data audit.
• Good Knowledge on handling the application software

Experience: 13-18 Years\' Experience

Behavioural Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

Equal Opportunity Employer:

It 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.

Syngene International