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| Company: |
Makro Technologies, Inc. |
|
| Job Title: |
Quality Assurance Manager |
| Job Category: |
Biotech |
| Job Location: |
CA California - USA |
| Job Ref. Number for your records: |
QAM_1508 |
| Job Description: |
Urgent requirement for one of our top clients located in “Emeryville, CA”.
Please contact me at your earliest convenience, along with job No. QAM_1508
Job Description:
Perform a variety of activities to ensure compliance with applicable regulatory requirements and facilitate the management of third-party contract manufacturing organizations. Participate in the design, establishment and maintenance of programs and processes that ensure quality products and compliance with current Good Manufacturing Practices (cGMPs) for pharmaceutical, biotech and drug/device combination products. Author, edit, review, and approve policies, SOPs, and guidance documents. Manage and administer processes within the company’s Quality System. Collaborate with functional groups and contract manufacturers to evaluate and address complex issues such as deviations, technical complaints, corrective and preventive action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventive action (CAPA) recommendations related to products. Lead or assist compliance audits (GMP, GLP, GCP, Internal and Supplier/External). Work with R&D as QA representative during new product start-ups, and identify routine checkpoints for new products and processes. Contribute to the completion of CMC sections of regulatory submissions. Provide Quality oversight for the labeling, packaging, storage, and distribution of clinical trial materials.
Contact:
The most effective way of communication is via email. Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us. |
| Skills Required: |
Requirements:
Bachelor’s or Master’s Degree in a relevant scientific discipline with 5+ years demonstrated QA experience in a pharmaceutical or biotech company. Prior compliance work with sterile product, aseptic manufacturing processes, or drug/device combination products is highly desirable. Must have an understanding and application of FDA regulations and guidances, QA principles, concepts, industry practices, and standards. |
| Language Requirements: |
English-Very Good
|
| Employment Type: |
Full Time
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| Yearly Salary: |
110000 USD
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| Posting Date: |
Jan 05 2008 |
| Education level required: |
Bachelor
|
| Experience (in years): |
5 to 7 Years |
| Job also available in: |
Emeryville |
| Company: |
Makro Technologies, Inc. |
| Contact Name: |
Makro Technologies, Inc. |
| Contact Phone: |
973.481.0100 |
| Preferred Method of Contact: |
E-mail via Apply Online Box |
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| Jobseekers:74399 |
CVs:68494 |
Employers:8480 |
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Language:english |
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