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Job Description
- Responsible for receipt, analysis and management of innovator samples.
- Responsible for Method development of finished product according to the regulations of pharmaceutical industry.
- Responsible for Method validation according to the regulations of pharmaceutical industry from preparing the protocol to the final report that summarizing the data.
- Responsible for Cleaning method development preparation and validation
- Responsible for follow up application of good laboratory practices covering activities performed in Quality control department.
- Prepare test method of analysis for new products (R&D trials).
- Perform invitro comparative Dissolution Protocols and Reports for different types of products "Tablet, Capsules and Suspension.
- Troubleshoot and resolve operations issues.
- Conduct training to fresh analyst.
- Prepare SOP related to methodology department.
- Contribute with other departments (QC, QA & RA).
- Responsible for fulfilling all regulatory requirements related to methodology department.
- Participate in out-of-specification and failure investigations.
- Responsible for preparation of NODCAR files for submission for regulatory aspects
- Responsible for preparation of CTD files for submission for regulatory aspects
- Responsible for preparation of Export files for submission for regulatory aspects.
Job Requirements
- Bachelor of Pharmacy or Science.
- 6-8 years of experience (at least one-year experience as Methodology Supervisor).
- Excellent verbal, written and interpersonal communication skills.
- English fluency is essential
- Professional computer and MS-Office skills
- Professional analytical skills
- Strong organizational and multitasking skills
- Attention to details