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Opportunity for Ph.D, M.Pharm, M.Sc as Senior Manager at Syngene International

 

Clinical courses

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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