ProClinical is seeking a CMC QA to be based in Shanghai on a permanent basis.
- Oversight of development and approval of HPLC and other test methods for release and stability testing of company's drug substances and drug products.
- Quality Control review and approval of technical documents including but not limited to process validation protocols, assay validation protocols, technical transfer methods, stability protocols and all respective final reports.
- Ensure compliance with applicable laws, regulations and guidelines for contract manufacturing organizations.
- Act as representative between QA department and contract manufacturers and testing laboratories.
- Provide quality and compliance oversight of the quality systems at CMC and those of contract manufacturing, testing, research, laboratory and storage and distribution organizations including, but not limited to:
- Deviations/Quality Events
- OOS investigations
- Corrective and Preventive Actions
- Risk Management
- Document control
- Change control
- Validation (e.g. software, process, cleaning, analytical method, etc.)
- Batch record review
- Product disposition
- Vendor qualification and auditing
- Contractor qualification
- Internal auditing
- Quality/Technical and other agreements
- Liaison with Technical Operations CMC Department as the representative for Quality Assurance.
- Draft and revise Quality Assurance controlled documents.
- Review and approve GMP related documents as requested and appropriate.
- Ensure appropriate record-keeping of all related documents for compliance.
Skills and Requirements:
- Bachelor's degree in relevant technical or scientific field, Chemistry or Biology preferred.
- Minimum 1-3 years of experience working in the Biotech or Pharmaceutical Industry in Quality Assurance.
- Working knowledge of cGMPs and applicable international regulations and guidelines.
- Self-motivated with a solid sense of ownership in areas of responsibility.
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
- Detail oriented and the ability to handle frequent changes in product activity.
- Quick learner with the ability to independently plan, prioritize, multi-task and follow through on responsibilities.
- Solution driven team player.
- Ability to work on multiple projects simultaneously and demonstrate organizational, prioritization and time management proficiencies.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lily Zhao on +86 21 5169 4106 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Up to £65 per hour
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