RECRUITMENT

招賢納仕

Recruitment Information

招聘信息

Associate Engineer/Technician

Place:Shanghai

Job responsibilities

Job Responsibilities should include but not limited to the following:

Literature search for new products.

Formulation development of different dosage forms

Preformulation studies, innovator, sample evaluation, stock maintenance.

Planning and execution of Lab scale experiments.

Optimization of products and process parameters in line with patent non infringement development strategy.

Preparation of stability protocol, master manufacturing formula, product development reports.

Compilation of trial details, stability reports and analytical reports, lab note book compilation.

Calibration of Balance and pH meter.

Indenting API punches and excipients as per product requirements

Requirement

Required Education and Capability:

Master degree in Pharmaceutical Sciences/Chemistry, or related discipline and 1-2 years of experience in formulation development of different dosage forms.

Experience in GLP and SOP practices. 

Good written and verbal communication skills.

Experience in preparing the technical documentation.

Must have good knowledge of cGMP requirements for product development.

Proficiency in working on routine use software.

Group Leader/Analytical Senior Engineer/Analytical Engineer

Place:Shanghai

Job responsibilities

Job Responsibilities should include but not limited to the following:

Understanding the planning & pipeline for the activities related to analytical activities based on the defined time lines

Planning & providing analytical support during design, optimization, validation and transfer

Collaborating with associated departments to support drug product quality attributes, testing

Leading scientific team of analytical scientists and to work in close association with them (individually/group) towards achievement of goals

Supporting to organization in the establishment and up - gradation of  SOP’s

Involving in the improvement the analytical aspects of product through method improvement

Ensuring to implement relevant industry best practices and regulatory guidance.

Updating the up-level manager for important issues and escalating potential critical issues in a timely manner.

Contributing to analytical inputs as required by QC team at manufacturing sites.

Generating analytical reports at different stage of analytical developmental activities.

Documenting all the developments in experiments.

Following the guidelines set by the different regulatory bodies.

Requirement

Required Education and Capability:

Masters/Bachelor in analytical chemistry, pharmaceutical chemistry or related scientific discipline with about 3-5 years of experience in analytical activities.

Revealed scientific knowledge and experience in analytical science in drug product development with  knowledge and experience in the development and validation of test methods  (assay/impurity analysis, dissolution testing)

Excellent written and verbal communication skills.

Must have good knowledge of GMP requirements for product development.

Firm knowledge of applicable global drug development and regulatory standards

Experience with CMC technical sections of regulatory submissions

Strong analytical and strategic thinking with problem solving capabilities

Profound communication skills (oral, written, presentation)

Analytical Associate Engineer/Analytical Technician

Place:Shanghai

Job responsibilities

Job Responsibilities should include but not limited to the following:

Executing the experiments related to analytical activities to meet defined time lines to support development, optimization, validation and transfer

Having the sense of urgency to support supervisor and cross functional teams to promptly address product issues

Performing different analytical activities using different instruments like GC, HPLC, Dissolution apparatus, water determination etc.

Performing the calibration of different analytical instrument

Managing of laboratory consumable items & reagents

Interacting with associated departments to generate data to define drug product quality attributes, testing methods & stability profiles.

Providing practical inputs in the up- gradation of  SOP’s

Providing data support to generate analytical reports at different stage of analytical activities.

Updating the up-level manager for important issues and escalating potential critical issues in a timely manner.

COA Documenting all the experiments & observation in the notebook and generation of certificates of analysis

Ensuring compliance to GLP/GMP/SOP system

Supporting and contributing analytical inputs to QC team at manufacturing sites

Requirement

Graduate in analytical chemistry, pharmaceutical chemistry or related scientific discipline with about 0-2 years of experience for Associate Engineer; Bachelor or High School degree in Sciences /Chemistry, or related discipline for Technician.

Sound theoretical knowledge in analytical science. 

Good communication skills (oral, written) & IT skills. 

Follow good laboratory practices.

Should be a self-starter and self-motivated.

Capability to prioritize and effectively manage workload.

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