Job Ref. ID:
Analytical Development Assistant Officer
Research & Development
UNITED ARAB EMIRATES
UAE (RAK head office)
Research & Development - Analytical Assistant Officer
Full Time Employment (Un-limited Contract)
The Analytical Development Assistant Officer will be responsible to conduct comparative dissolution profile of generic products versus reference products also to develop and validate robust analytical test methods and validation according to the international requirements and guidelines (FDA, ICH, GCC, WHO) to support formulation development, stability testing, and quality control testing of new pharmaceutical formulations, ensuring delivery in accordance with project deadlines. The position is also responsible for any analytical investigations and problem solving.
Key responsibilities & Accountability:
Comparative dissolution profile of generic products versus reference products. Analytical Method Research and Development of generic pharmaceutical products. Validation of in-house analytical methods and verification of pharmacopeias analytical procedures. Transferring new analytical techniques to the concerned departments. Writing standard the analytical procedures, validation and method transfer protocols and reports. Assigning specification of drug products/drug substances (e.g. limits of related substances, dissolution, assay, preservative, etc.). Conducts stability testing for products for new formulations. Dealing with OOS and resolve any analytical issues. Observes and complies with the Company Standard Operating Procedures (SOPs). Writes and reviews Standard Operating Procedures for Analytical Section of the department. Maintaining analytical equipment and calibration (HPLC, GC, Spectrophotometer, Atomic Absorption, pH Balance, columns, etc). Controls laboratory chemicals required for analytical development activities. Responsible for outsource and maintains the equipment for development activities. Complies with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Documentation Practice (GDP). Preparing daily work plan and report. Complies with Company Health and Safety Policies. Participates in self-inspections and regulatory inspections. Collaborates with all members to maintain and develop the positive progressive culture. Ensures good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers. Undertakes any other duties and other responsibilities which may be requested by the Manager/Director.
Bachelor/Master in Chemistry or Pharmacy.
Has at least 4-6 years of relevant experience in pharmaceutical analytical research, CDPs and analytical methods development and validation. Has experience in providing stability testing support of drug products and drug substances.
- Specialized Knowledge and Skills:
Has excellent oral and written communication skills. Has in-depth knowledge of drug products and quality. Ability to work under pressure/crisis situations and results oriented. Ability to work in second/third shift.
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