The major responsibility of the methodology Junior specialist is to perform method validation and verification activities. Routine job responsibilities include the writing and executing of method validation protocol and reports. The Junior Specialist will demonstrate technical expertise in QC functions and will provide expert levels of technical troubleshooting to the QC team. The Junior Specialist will work in a detail-oriented, compliant manner in a fast- paced, moderately stressful environment, on multiple concurrent projects. The Junior Specialist is expected to adhere to tight deadlines with shifting priorities. The Junior Specialist is expected to perform review of generated data for conformance to approved quality standards and must report any nonconformance or deviations to management in a timely manner for immediate required action. The AS&T;Junior Specialist will report to Analytical Science & Technology Manager and efficiently conduct all duties and responsibilities assigned and or delegated by the AS&T;Manager.
Key responsibilities & Accountability:
Daily set-up, operation, troubleshooting and maintenance of instrumentation such as HPLC, UV, GC, KF, FTIR, and A.AS in accordance with written SOPs
Participating in protocol development and execution for test method validation / verification and related activities
Maintain lab work area and documentation in a neat and orderly fashion
Maintain data within a laboratory notebook in a legible, organized, and compliant manner, and transcribes or enters data into necessary records in an accurate and timely manner
Reviews generated data in a timely manner and elevates any Non- Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation.
Performs investigative testing or other functions to assist with laboratory investigations.
Works in support of development projects and may require weekend, off-shift work, or overtime as necessary to complete high priority work assignments
Follows procedures and completes required documentation or updates as appropriate as part of Periodic review process
Works on development products, methods and projects to support R&D;initiatives.
Works with computers as well as laboratory software, or proprietary software as needed.
Follow GLP, GMP and safety procedures and maintain hygienic conditions in lab.
Evaluation of column as per the Qualification, Calibration and Evaluation schedule.
Fill the related SOP Attachment after performing the calibration and Label the Instrument
Reads and follow Equipment & Quality SOP s.
Follow safety during work and all plants.
Maintain and demonstrate a high level of personal and professional integrity and Report any suspicious activity to laboratory management.
Additional responsibilities may be assigned by Laboratory Management as needed.
Qualifications:
- Education
B.Pharm /M.Pharm or B.Sc/M.Sc. Chemistry or Biochemistry.
- Experience:
At least 1-year experience working in the method validation/Verification/Method development and method Transfers.
A Strong Background in Analytical Method Validation/Verification of In- House Method Development and Pharmacopoeia Drug Products.
Strong Background in the raw material & Finished products specification setting.
Prior experience in a pharmaceutical (cGMP) laboratories setting is a must.
- Training:
Key Competencies:
Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
Strong organizational skills and the ability to multitask
Demonstrated ability in working independently and as part of a team
Must be able to work in a cross-functional environment interacting with other internal departments.
Excellent communication (oral and written) and interpersonal skills
Must be able to communicate technical, scientific, and regulatory information, both written and verbally
Ability to work in a detail-oriented manner
Ability to meet attendance standards. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.
Technical Competencies:
Major Expertise in Chromatography, Dissolution and spectroscopy. Trained on FDA 21 CFR Part 210 and 211 regulations.
Demonstrated technical expertise in instrumental laboratory analysis.
https://www.naukrigulf.com/methodology-junior-specialist-jobs-in-uae-in-julphar-3-to-4-years-n-cd-10003634-jid-050221500058
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