Senior QC Chemist (Analytical Science & Technology)

Position Title: Senior QC Chemist (Analytical Science & Technology)

Location:Tuas,Singapore

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

1. Access – Providing high quality trusted medicines regardless of geography or circumstance,
2. Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
3. Partnership – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how this role will make an impact:

Job Summary

The incumbent is member of AS&T team. Under the supervision of AS&T manager or QC Laboratory Supervisor, the incumbent will be responsible for performing analytical method transfers from donating site, testing, review of test results and provides technical support to the laboratory. In additional to method transfers the incumbent supports for cleaning method development and its validation. The incumbent will also needs to assess the compendial monograph updates for the TUAS site products and provide technical & regulatory support for the post transfer products.

Key Responsibilities and Accountabilities

• Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements.
• Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
• Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed.
• Able to assess the impact to products based on compendial monograph changes/updates/introduction.
• Able to support regulatory submissions and queries for post transfer activity.
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
• Conduct Laboratory investigations and propose CAPA for the identified root cause.
• Train colleagues in hands on training of instruments and methods written
• Perform review and approval of test results.
• Able to write position paper, protocols, reports and test procedures.
• Ability to handle QTS actions and raise and complete change controls for changes with GMP impact.
• Involve in regular meeting with donating site and facilitate the smooth transfer of the methods.
• Conduct training for fellow QC colleagues on new methods in the laboratory.
• Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution.
• Perform cleaning method development and validation.
• Ensure following the site GDP practice on documentation and preparation of document.
• Method verification in accordance to site or pharmacopeia standards and according to schedule.
• Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities.
• Analytical testing, method transfers and review of test results to meet lead time in a right first time manner.
• Perform testing according to Standard Work Plan (SWP) as assigned.
• Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities.
• Method verification in accordance to site or pharmacopeia standards and according to schedule.
• Support to QC for method trouble shooting.
• Evaluate method robustness challenges and modify the method to improve method robustness if required.
• Involve in regular meeting with donating site and facilitate the smooth transfer of the methods.
• Compliance to GMP/GLP and Viatris requirements.
• Understand and comply with Data Integrity and Good Documentation Practices (GDP) requirements.
• Laboratory safety and housekeeping; and participate in laboratory housekeeping and 5S program responsibilities.
• Wear Personal Protective Equipment (PPE) as required and observe safety instructions stated in Job Safety Analysis (JSAs), Standard Test Methods (STPs) , Material Application Document (MADs), and Laboratory Document (LAB).
• Perform test method validation & cleaning method validation of test methods in accordance to STP and USP/JP/EP requirements
• Complete validation documents reports as required.
• Update SOPs to align with Viatris Policy and regulatory requirement (USP, ICH guidelines etc)
• Provide guidance to the team on the good practice and approach for AMTE, Method Validation, Method Verification and other relevant activity.

Candidates are expected to have the following qualifications, skills, and experience.

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:

• Degree or Diploma in Science (preferably Chemistry).
• For a Diploma: A minimum of 9 years QC experience in the pharmaceutical or related industry.
• For a Degree: A minimum of 6 years QC experience in the pharmaceutical or related industry.
• Demonstrated technical skills in method transfer, validation, verification and testing
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Knowledge of Good Manufacturing Practices and its application standards, processes and policies
• Excellent organizational skills and strong ability to multi-task across projects and activities.
• Strong written and verbal communication skills
• Laboratory work experience with analytical HPLC, GC, FTIR, UV, KF and other lab equipment.
• Experience leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics
• Experience in Method Transfer, Method Validation and Method Verification activity.