At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
Roles & Responsibilities
- Responsible to adhere with the cGMP principles and ensure that all laboratory activities are within safety procedures.
- Accountable for Method development, method validation and assist in formulation development from analytical point of view
- Initial analytical methods of analysis, validation protocols and validation reports.
- Analyze operations results and performing variance analyses.
- Provide recommendations and requirements of equipment, instrument and / or reagent required for new Test Methods to enrich the lab area and system.
- Provide technical support within analytical research laboratories and other laboratories when needed.
- Responsible for carrying out feasibility studies to develop method with low-cost concept.
- Maintain the equipment in working conditions and arrange calibration when required.
- Support Registration department with related requirements for Method and Validation documents.
- Post registration and support to fulfil the regulatory requirements.
- Organize and storing data for any future research.
- Ensure that any data collected, analyzed and or shared while performing these duties is handled in line with data protection and data storage and collection policies and protocols.
- Maintain the analytical data integrity, laboratory records, reports and logbooks.
- Maintain Analytical records and availability of chemicals, glassware and reference standards (working /Primary Standards) with COA.
- Contribute to the development of new products, evaluation tools/methods and improved systems.
- Accountable to take part of stability study and write protocol and plan for New Stability Indicating Test Method Development, Validation and Part of Bioequivalence study dissolution rate.
- Responsible for writing SOP's for equipment, cleaning and calibration to comply with cGMP.
- Preform any other work assigned by Manager and support colleagues whenever necessary.
- Handling of injectables and Biosimilar products
Qualification/Functional Knowledge
Education
- Bachelor's degree in pharmacy/ chemistry or related Sciences.
Experience
- 6-8 years experience in the Product Development/Research and Development from a Pharmaceutical field.
- Hands on expertise in Research & Development and analysis of solid, semisolid, injectable, liquid oral dosage forms
- Should have handled similar role for a better fitment of this role.
- Advance knowledge of the related field and always be in the forefront in implementing Best Practices from Industry.
- Skilled in Science - Using scientific rules and methods to solve problems.
- Proven experience of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
- Advance Knowledge of statistics, and their applications.
- Strong Knowledge in international guidelines such as ICH, USP, EP, BP and WHO. Scientific approaches in method development and method validation. Different instrumentation and instruments trouble shooting. And analytical trouble shooting.
We value people from different backgrounds. Could this be your story Apply today or visit www.Julphar.net to read more about us and the journey of Julphar
