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The Position

Roles & Responsibilities

Routine Operation:

Perform the physical and chemical testing on the samples from incoming raw materials and packaging materials produced bulks and products environment monitoring process validation and cleaning validation etc. Issue the reliable analytical report in reasonable lead time.

Adhere to all effective SOPs and safety requirements and document laboratory work consistent with cGMP requirements

Assist Head of Analytical Testing lab to complete GMP Self-Inspection as well as the relevant CAPAs to maintain the global level of GMP compliance. Presents technical analytical data clearly and concisely to internal investigations and regulatory inspectors.

Accomplish the calibration and maintenance of assigned instruments to ensure they are in good order to meet the analytical needs any time.

Report the abnormal status unexpected results to supervisors with initiative.

By reporting abnormal status and unexpected results during analysis processing by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.

Maintain laboratory cleanliness and inventory of bioanalytical materials and cell supplies

Supports lean initiatives in the area of lab operations test method execution documentation updates and equipment qualification

Engineering Project Support and Operation Readiness:

Analytical method transfer execution: Support and execute the analytical method transfer for the aseptic product.

Analytical Method Validation and Qualification: Execute the methods comparison qualification and validation activities.

Equipment Support: Support the Performance Qualification (PQ) of laboratory equipment and ensure routine operation.

Qualification and Experience

Education/Qualifications

• Bachelors Degree (Life Sciences Microbiology or Analytical Sciences is preferred) and above

Job Required Competencies

• 2 or more years of QC experience QC experience with a focus on bioanalytical and bioassay testing. MNC Bio-pharma experience is preferred

• Sound knowledge of quality control procedures and legal standards with experience in aseptic assurance and physical and chemical testing.

• Experienced in QC new facility startup readiness and operation ramp up is preferred.

• Fluent communications skills in English

• Project management skills is preferred.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.