Responsibilities
- Site Product Manufacturing and Release Support. Provide front line support to the product manufacturing process analytics, release testing and working with the QC teams (internal sites), or in close collaboration with CDMO Analytical Expert counterparts, focusing on the testing methods for each batch, their release on time and in compliance with the batch and analytical procedures instructions and quality requirements.
- Qualification & Validation. Support the execution of analytical methods qualifications and/or validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor (internally) or CDMO manufacturing team (externally) to ensure accurate execution. Review and ensure that qualification / validation protocols and report are technically correct and in compliance with all applicable international guidelines and requirements. Ensure protocols are executed, as intended.
- Technical improvement execution. Execute analytical methods improvements and support methods development for additional product and/or process related characterization studies.
- Ensure that process technical batches generate sufficient analytical methods knowledge by thoroughly testing critical variables (e.g., DOE, QbD, PAT).
- Primary packaging closure assessment during changes. Drive the qualification and/or validation of primary packaging materials testing methods including the design of container suitability studies for the assigned product(s). Evaluate and ensure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality.
- Assure consistency of Analytical Testing Procedures. Ensure that all critical and significant parameters are within written Instruction (e.g., Testing procedures, Validation Plan), sufficient and appropriate for the product. Derive in collaboration with the internal sites (QC team) / CDMO analytical team, the upper and lower control limits for each product analytical methods (where relevant), as part of the CPV program launch for all products
- Deviation, Out of Expectation, Out of Specification, complaint handling. Lead and/or support the GPS organization with all product and process related analytical investigations and deviations including complaints, Out of Expectation, Out of Specification, in partnership with internal / external site analytical teams. Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
- Annual Product Reviews and Product Quality Reviews. Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations. Be a resource to other departments as Subject Matter Expert for the product and process knowledge.
Requirements
- BSc. In Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or equivalent scientific degree. Desirable MSc. or equivalent experience.
- Minimum 5 years experience as QC/IPC laboratory scientist of pharmaceutical /chemical GMP environment, or analytical methods development scientist.
- Basic knowledge of current CPV / OPV product and process data analysis and monitoring tools and usage
- Fundamental understanding of international regulatory requirements across multiple health authorities is a plus.
- Fundamental understanding of standard pharmaceutical analytical testing and methods development.
- 5S / 6S Lean Six Sigma Certification.
- Fluent in Japanese speaking a plus to liaise with Native Japanese stakeholders and headquarter.
- 1 year contract with full benefits (21 days annual leave, medical + completion bonus), MNC with possibility of conversion.
- Job Reference: L84839Y3
All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.
Kindly email your resume in a detailed Word / pdf format to [Confidential Information]
We regret that only shortlisted candidates will be notified
People Profilers Pte Ltd
Tel: 6950 9753
EA Registration Number: R1111375
EA License number: 02C4944
EA Personnel: Ashley Lee Hui En
