Method Validation Researcher

منذ 2 أيام

Alexandria, مصر Pharco Pharmaceuticals دوام كامل

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R&D Method Validation Researcher

Department: Research & Development (R&D)
Function: Analytical Method Validation

Job Purpose

Execute and coordinate analytical method validation and verification activities to ensure analytical methods are accurate, reliable, reproducible, and compliant with applicable regulatory requirements and international guidelines.

Key Responsibilities

Execute analytical method validation and verification studies for pharmaceutical raw materials, in-process samples, and finished products.
Perform analytical testing using laboratory instruments, particularly HPLC, GC, UV-Vis, and FTIR.
Evaluate validation parameters, including specificity, accuracy, precision, linearity, range, robustness, LOD, and LOQ, as applicable.
Prepare, review, and maintain validation protocols, analytical procedures, raw data, and validation reports.
Perform analytical method transfer activities between R&D, QC, and other relevant laboratories.
Conduct analytical troubleshooting and investigate unexpected results or method-related issues.
Ensure compliance with ICH guidelines (ICH Q2(R2) and ICH Q14), GMP, GLP, and data integrity requirements.
Participate in laboratory investigations, deviations, change controls, and CAPA implementation.
Coordinate with Method Development, Stability, Quality Control, and other R&D functions to ensure effective execution of analytical activities.
Ensure proper calibration, qualification, and maintenance of laboratory instruments.
Maintain accurate laboratory documentation in accordance with approved SOPs and regulatory standards.
Contribute to continuous improvement of analytical methods and laboratory practices.

Job Requirements

Bachelor's degree in Pharmacy or Science (Chemistry).
2–5 years of relevant experience in Analytical Method Validation, Analytical R&D, or Pharmaceutical Quality Control.
Practical experience with HPLC and GC analytical techniques.
Good understanding of analytical method validation principles and parameters.
Knowledge of ICH Q2(R2), ICH Q14, GMP, GLP, and pharmaceutical regulatory requirements.
Experience in analytical method transfer and troubleshooting is preferred.
Good command of English and MS Office applications.
Strong analytical thinking, attention to detail, documentation, and problem-solving skills.
Ability to work effectively within cross-functional teams.

Method Validation Researcher

احفظ هذه الوظيفة وحافظ على تنظيم بحثك

R&D Method Validation Researcher

Job Purpose

Key Responsibilities

Job Requirements

وظائف مشابهة في Alexandria

أهم المدن

الأمريكتين

أوروبا

آسيا / أوقيانوسيا

أفريقيا

Method Validation Researcher

احفظ هذه الوظيفة وحافظ على تنظيم بحثك

R&D Method Validation Researcher

Job Purpose

Key Responsibilities

Job Requirements

وظائف مشابهة في Alexandria

أهم المدن