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Performs QA oversight of production and testing activities (shop-floor presence), ensuring compliance with cGxP and ISO9001 standard. incl. DI and eCompliance, eg. as OQA SPOC. Acts as reviewer/approver of production and QC records and documents, incl. MBR. Provides specialist support in the evaluation and execution of the investigations and changes.

Major Accountabilities

Operational

?Provide shop-floor QA support and oversight of production and testing activities, ensures compliance with cGxP, ISO9001, incl. data integrity and eCompliance

?Batch document review, support product release

?Support deviation and compliant investigations within MU, QC, Engineering and warehouse and other relevant areas.

?Performs routine documentation activities

?Supports change control activities

?Review and approval of production and QC documents and records

?MBR review

?IPC oversight

?Support OpEx improvement projects

?Support internal and external audit or inspection activities

HSE

?Comply with all HSE guidelines

?Detect and report potential accident, risks and propose solutions

?Participate in HSE risk assessments

?Preparation and participation to internal HSE audits

?Responsible for participating in initial training and retraining

Key Performance Indicators

?Executes product-related activities in timely manner according to cGxP and in compliance with registration

?Demonstrated positive trends in key quality management process measures. Successfully support continuous improvement projects

Experience:

?More than 3 years of experience in pharmaceutical quality control, quality assurance or production

?Operations Management and Execution

Functional Breadth

Collaborating across boundaries

Applied Practice

Education & Qualification:

?University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

?Qualified Person (depending on local requirements)

Languages:

Good (oral and written) in English

fluent in local language (oral and written)

為什么選擇諾華：幫助患者及家屬不僅需要?jiǎng)?chuàng)新科學(xué),，還需要一支包括你我他在內(nèi)的充滿(mǎn)智慧與激情的團(tuán)隊(duì)，大家相互協(xié)作,、支持與激勵(lì),。共同實(shí)現(xiàn)突破，改變患者的生活,。一起共創(chuàng)更好的未來(lái),，你準(zhǔn)備好了嗎？

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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Technological Expertise

Dealing With Ambiguity

Gmp Procedures

Self-Awareness

Continued Learning

Technological Intelligence

Quality Standards

Quality Control (Qc) Testing

Qa (Quality Assurance)