公司簡(jiǎn)介

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)
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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)