Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Post : Senior Manager
JOB PURPOSE
Senior Manager to oversee the activities related to QC/analytical for developmental and validations group
Job Description:
• Responsible for the functioning of method development and validation activities.
• Allocate project to team members depending on the complexity of the project and the competencies of the employee in the team.
• Hands on experience in Drug product analytical method development for injectable.
• Hands on experience in Reference standard characterization
• Hands on experience handling on compendia methods
• Method development for Experience in E&L studies
• Interaction with team members for technical troubleshooting in Lab.
• Monitoring of chemical inventory management pertaining to the team activities.
• Review of specifications, protocols, validation, verifications, Qualifications and relevant reports.
• Handling of Client complaints relating to quality of the analytical data.
• Review of Instrument / Equipment Qualification and calibration data.
• Regular client interaction via telecom or e-mails.
• Responsible for implementation of Corrective and preventive actions.
• Adherence to Good Laboratory Practice.
• Responsible for coordination with Maintenance Department.
• Review of SOP,s IOP,s and calibration documents.
• Training of personnel in Quality Control.
• Responsible in investigation of Incident and deviation.
• Responsible for maintaining and reviewing the Annual calibration schedule.
• Handling and review of change control activities.
• To guide the team members to execute and complete the project work on time as per the client requirement.
• To ensure the lab compliance as per the regulatory requirements. To ensure all the instruments and equipment inside the lab are calibrated and maintained properly as per the quality requirement.
• To review all the documents generated within the team during the development, validation and stability study of the projects for technical and GDP compliance.
• Management of OOS, OOT, OOL, and invalid assays, and perform root-cause analysis using different tools like 5 WHY, Cause & Effect, Pareto analysis. Management of COC and CAPA
• Preparation, review and approval of quality documents like Standard Operating Procedures, Work Instructions, Technical documents, Quality Review documents, Analytical Instrument Qualification Protocol & Reports and its Release Notification. Preparation, review and approval of Analyst Qualification, Cleaning Validation, Method Validation and Stability Protocols and Reports. Answer regulatory queries
• Hands-on experience in electronic systems like ELIMS, Empower3, Track wise System, SAP and Compliance Wire for Training Management
Candidate Profile
• M. Pharm, M.Sc. or PhD – Analytical Chemistry
• 15 & above years (with MSc) /10-12 years (with PhD) of relevant experience in QC or Analytical
• Should have very good communication skills & technical report writing skills
• Should be familiar with cGMP and ICH guidelines and related compendia procedures
• Analytical method development and method validations
• Technical skills in HPLC,GC, LC-MS,GC-MS,DSC,TGA, ICP, AAS, KF and TOC etc…
• Good communication, technical report writing skills and E- Mail etiquette
Additional Information
Qualification : M.Sc, M.Pharm, Ph.D
Location : India
Experience : 10-15 years
Industry Type : Pharma
End Date : 10th October, 2018
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