Title: REVIEWER

Date: 26 Dec 2024

Job Location: Bangalore

Pay Grade

Year of Experience:

Job Description

Designation: Assistant Manager

Job Location: Bangalore

Department: QUALITY ASSURANCE COMMON- SMALL MOLECULES

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

QA Reviewer- Management Information Data

Job Description

Job Description:

• Review of Management Information data and Key performance indicators for Small Molecule Quality.
• Pharmaceutical quality Data analysis, interpretation, trending, visualization and presentation of Quality data using IT tools like Power BI, Power Point presentations, Excels, AI tools.
• Tracking and driving action plan for red KPIs and quality risks.
• Strategic initiative data analysis and Trending of small molecule quality data.
• To drive and support quality excellence programs in quality function.
• Implementation of Lean six sigma, 5S and Kaizens.
• Communicate promptly and effectively with the clients and Cross-functional team members.
• QMS investigations, root cause analysis and QMS Trending.
• Corrective and Preventive action (CAPA) identification, implementation and effectiveness monitoring.
• Change control management and effectiveness of change management.
• Preparation and Review of GMP documents like Quality agreements, Site Master File (SMF), Quality Manual, Master Validation Plan.
• Quality risk management and risk assessments.
• To face customer/third party cGMP audits, regulatory audits and internal quality audits. Audit response writing and CAPA plan.
• Vendor audits and vendor management. Qualification of contract testing laboratory.
• Preparation and review of SOPs, protocols, schedules, audit responses and other GMP documents in EDMS.
• Review of Equipment qualification and Computer system validation (CSV) documents.
• Implement improvement ideas and appropriate measures to reduce Non-conformances and to increase efficiency and productivity.
• Effective implementation of self-inspection program to ensure zero observation in the internal and external audits.
  
  

Key Responsibilities

• Handling of Management Information data and monitoring of Key performance indicators for Small Molecule Quality.
• Tracking and driving action plan for red KPIs and quality risks.
• To drive and support quality excellence programs in quality function.
• Implementation of Lean six sigma, 5S and Kaizens.
• Communicate promptly and effectively with the clients and Cross-functional team members.
• QMS investigations, root cause analysis and QMS Trending.
• Change management and risk assessments.
• Vendor audits and vendor management. Qualification of contract testing laboratory.
• Preparation and Review of GMP documents like Quality agreements, Site Master File (SMF), Quality Manual, Master Validation Plan for Small Molecule quality.
  
  

Educational Qualification: M.Sc. / M. Pharma/ B. Tech.

Technical/functional Skills

• Experience in Pharmaceutical Quality control, Quality assurance and manufacturing (API, Formulations, Injectables).
• Excellent English Language proficiency and good communication skills.
• Excellent in Information Technology tools like Power BI, Power Point presentations, Excels, AI tools.
• Presentation skills and data interpretation.
• Pharmaceutical Quality Data analysis and trending.
• Well versed with EQMS Trackwise, and EDMS applications.
• Well versed with analytical laboratory softwares like LIMS, Chromeleon and Empower softwares.
• Qualified QMS investigator and Trainer.
• Qualified auditor as per ISO 9001 or equivalent.
  
  

Experience: 8 to 12 Years

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 be 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.