Job Title: |
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Quality Assurance Compliance Manager |
Category: |
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Quality Assurance (QA) |
Total Positions: |
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1 |
Job Location: |
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Islamabad |
Gender: |
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Male |
Age: |
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30 to 45 years |
Minimum Education: |
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Pharm-D |
Degree Title: |
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Bachelor’s of Pharmacy degree |
Career Level: |
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Department Head |
Minimum Experience: |
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4 Years6 Years |
Salary Range: |
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PKR 100,000 to 150,000 per Month |
Apply By: |
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Aug 3, 2020 |
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Job Description: |
Essential Job Functions:
- This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and, may be required to perform additional, position-specific tasks.
- Ensures compliance of Quality systems with current industry standards, guidance documents (e.g., DRAP , ICH, CDER , WHO)
- Participate in and approve facility investigations, using root-cause analysis.
- Proficient with investigation tools (e.g., fish-bone diagrams, 5-Why’s, FMEA techniques).
- Manage risk assessment initiatives and designate corrective actions for remediation (CAPA).
- Ensures compliance with current ANDA/NDA filings, organizes APR documentation.
- Review and provide technical assistance for protocol design for equipment qualification (IQ/OQ/PQ, software validation), process validation, and cleaning validation.
- Provides follow-up to site audits by writing response letters, and ensuring CAPA are completed in a timely manner.
- Other duties as assigned by the manager.
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Company Information |
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Company Name: Davis Pharmaceutical Laboratories Company Description: Davis Pharma is a manufacturing and marketing firm dedicated for protecting people of Pakistan from tragic diseases and death. We directly import raw material and produce wide range of quality medicines and market it throughout Pakistan through our distributional and institutional network.
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