Require Senior Executive at Syngene - M.Pharm, MSc Apply

Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Post : Senior Executive

Job Description
• Planning of day to day activities and reviewing of documents.
• To execute stability analysis, validations and method transfers on Flame emission spectrometry (FES), Atomic Absorption Spectrophotometer (AAS), Inductively coupled plasma Optical Emission Spectroscopic (ICP-OES) and Inductively coupled plasma mass spectrometry (ICP-MS) techniques as on required within timeline.
• Review of document generated on stability analysis, validations, method transfers and calibrations.
• Execution of validation protocols and routine analysis.
• Preparation of validation and stability protocols and reports.
• Preparations of Standard Operating Procedures (SOPs), Emergency Operating Procedures (EOPs) and IOPs and provide training whenever required.
• To prepare draft investigation report for the deviations, Incidents, Out of Control (OOC), and Out of Specification (OOS).
• To ensure the entire instrument for intended use meets the 21 CFR part 11 compliance.
• To oversee the quality aspects of stability operations and ensure the compliance for stability testing and Laboratory information management system LIMS
• Attend training on environment, health, and safety (EHS) measures imparted company
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

Candidate Profile
• M.Pharm / M.Sc
• 3-5 years of relevant experience in Quality Control department/Analytical Development Lab
• Good communication, technical report writing skills and E- Mail etiquette.
• Good team player
• Able to work follow instructions and perform the tasks under the supervision of the Team leader

Technical / functional Skills :
• Should have hands on experience on ICP-MS/ ICP-OES/ AAS and FES and other wet analysis instrumentation.
• Should be familiar with cGMP and ICH guidelines.
• Good knowledge on US/EU pharmacopoeias and its recent updates.
• Should be through with stability operations.
• Should have good hands on experience in execution of stability testing in line with ICH guidelines and strict adherence cGMP.
• Exposure to USFDA audits & thorough knowledge in maintaining the prerequisites in the implementation of 21 CFR Part 11 compliance will be treated as an added advantage.

Additional Information
Experience : 3-5 years
Qualification : M.Pharm / M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Department : Analytical - Baxter Global Research Center (BGRC)
End Date : 31st August 2025