Website Granules India LImited
Post Name: Analyst
Department: Formulation Analytical R&D
Grade: B/C
Reporting To: GM
Location: Granules – Gagillapur Plant –Hyderabad
Purpose: Provide support as a team member of Analytical R&D – responsible for Analytical development works.
Responsibilities:
Provide support in the Analytical development department, and in accordance to the New Product Development (NPD) Plan.
Support the team-lead in planning and directing activities within the Analytical Development in conjunction with other R&D functional areas, and interaction with Production, QA and Validation departments to produce R&D stability batches as per schedule to ensure the Regulatory approval and ultimately the commercial success of manufacturing new products.
Manage the HPLC and GC analysis and reviews of analytical test methods, development reports, specifications, STP’s, calibration of instruments, elemental impurities assessments, residual solvents declaration statement, COA’s and other related documents.
Provide support in day to day activities of analytical research lab as described below.
Planning of activities.
Approval of ATRs.
Compliance of instruments (calibrations, re-qualification and preventive maintenances).
Stability studies and makes decisions on data for regulatory submissions.
Ensuring safety at work place.
Ensuring the investigation analysis related to incidents, OOS/OOT and review of reports.
Method Validations as per USP/ ICH Guidelines to complies regulatory requirements.
Maintenance of documents produced in the department in traceable manner
Review of audit trails for the data generated in the ARD.
Alignment of ARD team towards FR&D requirements and fulfillment of project goals as per the timeline.
Liaising with internal customers and stakeholders to ensure coordination of all projects, and to oversee the resolution of all analytical issues while intervening in the highly complex or sensitive matters.
Attending the technical trainings.
Provide support for continuous improvement in existing procedures/practices/compliance of department.
Provide support in the overall management of the Analytical Development department and create a healthy environment of teamwork and empowerment, and promoting the AR&D values of creativity, integrity, excellence, perseverance, flexibility and respect.
Qualifications and Experience:
Masters degree or equivalent in Pharmaceutical or Chemistry or Pharmacy or Life Sciences 3-8 years’ experience in Analytical Research and Development in pharmaceutical industry.
Knowledge and Skills:
Knowledge on impurities quantification.
Candidates must have experience of working in a generic pharmaceutical company.
Demonstrated interpersonal skills.
Knowledge and application of GMPs, GLPs, and GCPs principles.
