Quality Specialist
1 month ago
Job Summary
:In this role the job holder will support the business to reach and keep compliance with China regulatory requirements, provide training as needed to ensure on going compliance to the China regulatory requirements.
You will implement, harmonize, and standardize elements of West quality systems as required by West Corporate QA. You will also support other quality related programs, as and when needed.
Essential Duties and Responsibilities:
Work closely with the program team to support the global/regional China DMF-related activities from pre-registration until post-registration. Manage Spec Justification and relevant document to the Master Specifications. Coordinate sampling process with Lab and site QA to ensure testing and release are completed on time. Work closely with team to initiate process of creating/updating item code as requested by customers. Provide historical analytical data to support capability studies for review of compliance to China requirements. Review data statistically and provide justifications for reduced testing as required. Writing technical reports as required to support China DMF submissions. Writing / updating existing QA documents related to China DMF project. Support necessary initiatives to continuously improve on the workflow and systems. Support, as required, customer technical/quality meetings associated with relevant China DMF submissions. Supports sites as needed regarding customer audits / complaint handling / site specific project as deemed required by the line manager. Interface with other West sites with respect to sharing of best practices and harmonization / standardization of West Procedures and practices. Responsibility for reporting/generating of quality data on a monthly, quarterly and or annual basis both internally and in support of customer meetings. Lead / support other Quality Improvements projects as directed by the line Manager. Support other QA functions in the plants where necessary. Other duties as assigned by manager.Basic Qualifications:
Education or Equivalent Experience: bachelor’s in chemistry, Chemical Engineering, or other Science based program. Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards and good knowledge of GMP. Desirable: Six Sigma qualification e.g., green / black belt. Min. 3 years’ experience in a GMP working environment.Preferred Knowledge, Skills and Abilities:
This role requires to attend evening calls with global / regional team. Effective communication and interpersonal skills. Ability to report technical details in a simple and concise manner. Good written and verbal communication skills. Proficient in Microsoft applications i.e., Word, Excel, PowerPoint and SAP system. Project management skills Customer Intimacy Collaboration Relationship building and contributing to team success. Strong analytical, communication, and interpersonal skills. Ability to work in a matrix environment. Must be able to travel as requested by the position. Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description Able to always comply with the company’s safety policy. Able to always comply with the company’s quality policy.Travel Requirements:
Must be able to travel up to 10% of the time.Physical and Mental Requirements:
Physical Requirements: Sedentary. Mental requirements: communication, quick decision making, interpreting data, reading or writing, public speaking, e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures.West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
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