Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives.
Post : Deputy Manager/Assistant Manager - Quality Control
Job Description
Role and responsibility:
This position reports to the Head - Analytical Laboratory and is responsible for review of Technical Data Package, plan and perform Stability analysis / Method Verification / Method Transfer / Validation, review of all analytical data, review of departmental SOP’s and training. Responsible for handling of Quality forms in Track wise, Track wise Harmony and handling of documents in Glorya EDMS.
Role and responsibility:
This position reports to the Head - Analytical Laboratory and is responsible for review of Technical Data Package, plan and perform Stability analysis / Method Verification / Method Transfer / Validation, review of all analytical data, review of departmental SOP’s and training. Responsible for handling of Quality forms in Track wise, Track wise Harmony and handling of documents in Glorya EDMS.
Main tasks:
- Planning / performing Stability analysis, Method Transfer and Method Validation: Planning for execution of Stability analysis, Method Transfer and Method Validation as per the relevant protocols, execution of pre-analysis based on the Technical Data Package / Verification and development of methods such as Assay, Related substances, Dissolution etc. for a drug as per the requirement. Review and maintenance of all log books of the department.
- Review of Technical Data Package:Review of Technical Data Package for stability drug products, to evaluate the feasibility of the method and to know the requirements, review of Method Transfer Protocol and Standard Testing Procedures in compliance with current guidelines, review of all stability/ method transfer/ method validation reports and analysis data.
- Review of Method Transfer / Method Validation protocols for drug products.
- Review of stability/ Method transfer and Method validation data. Method development and method verification for drug products.
- Review of departmental SOP’s, Calibration, Equipment validation protocols and Reports, review of departmental SOP’s, equipment validation protocols / data and calibration reports in compliance with current guidelines. Ensure the departmental activities are in compliance to cGMP
- Review and maintenance of all log books of the department.
- Initiation of Quality forms in Track wise, Track wise Harmony and handling of documents in Glorya EDMS, initiation of Quality forms in Track wise, Track wise Harmony and handling of documents in Glorya EDMS.
- Candidate Profile
• Should have Masters in Analytical Chemistry/Chemistry/ M.Pharm
• Must have 10+ years of experience in an analytical lab with most recent experience being in formulation.
• Should be knowledgeable in HPLC GC (instrumentation), Empower and LIMS(tools)
• Good knowledge in trouble shooting analysis
• Good interpersonal and communication skills
• Analysis of method transfer and stability analysis.Additional Information
Experience : 5+ years
Qualification : M.Pharm, M.Sc
Location : Chennai
Industry Type : Pharma
Functional Area : QC
End Date : 25th December, 2018
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