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QC/QA Coordinators |
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Experience at a Pharmaceutical Company
is needed. The successful candidate will ensure that all QA functions are
compliant with GMP regulations and consistent with company policies and
procedures in addition to conducting audits that insure continuous control over
materials, facilities and products throughout the production cycle, writing
SOP's and validation documents and responding to customer satisfaction issues.
the individual's essential duties and responsibilities include the following:
- Creation and review of SOPs and Quality Procedures.
- Perform Batch Record Reviews.
- Approval and maintenance of Change Controls and Deviation Reports.
- Review and approval of
Validation Protocols and Reports.
- Conduct In-house cGMP training and awareness
programs for Quality Assurance Inspectors.
- Coordination with various
departments for setting departmental procedures and devising systems for
documentation requirements.
- Managing Customer Complaints.
- Provide support in Regulatory Affairs and FDA audits to adhere to US-FDA requirements.
- Maintain Annual Product Reviews
of the various products being manufactured.
- Perform Internal Quality Audits
and provide support in handling audits by External Auditing Agencies.
- Monitor Non-Compliance reports
and take corrective actions to assure timely completion.
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