Job description

Job Summary/Main Purpose

The Specialist in the Quality Control division at Julphar HQ - RAK is responsible for adhering to cGMP principles and maintaining them effectively. The role involves carrying out chemical and physical analysis of finished products, raw materials, and stability samples, as well as process validation. The Specialist operates various QC equipment, follows GLP, GMP, and safety procedures, and maintains hygienic conditions in the lab. Additionally, the Specialist is responsible for entering data on SAP, recording all working data, assisting supervisors, training newly joined staff, and ensuring final products adhere to all specifications and regulations. The role also includes creating and processing HPLC & GC analytical methods, performing investigations for lab incidents, and supporting external and internal audits.

Key Responsibilities

• To adhere with the cGMP principles and to maintain them in an effective manner.
• Responsible to carry-out chemical and physical analysis of FP/RM/Stability, process validation
• Responsible for the operation of various QC equipment (depending on the section)
• Prepare to follow GLP, GMP and safety procedures and maintain hygienic conditions in lab
• Entering data on SAP.
• Responsible for recording all working data.
• Helps supervisors in assigned tasks
• To ensure and follow GLP, GMP, safety procedures and maintain hygienic conditions in lab.
• Training newly joined staff
• Entering and checking data of analyst on SAP
• Assist in trouble shooting and solving problems that may come up in the day-to-day operation of the department.
• Ensure Final Products adhere to all specifications and regulations.
• Create HPLC & GC analytical methods from approved STM/Pharmacopeia for all analysts before starting analysis
• Processing and approval for all HPLC &GC analytical data for all analysts, review and check all the Audit trial for all the instruments.
• To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis.
• To ensure the analysis is performed correctly as per applicable procedures
• To perform investigation for the lab incidents, OOS, OOT results, deviations and take appropriate corrective and preventive actions.
• To lock the results in SAP, to create notifications & reservations for maintaining enough stock of chemicals & consumables.
• To involve and support external and internal audits and to close the audit observations on time.
• Review and approve protocols and reports such as method validation, method transfer, process validation and stability.
• To handle and close the Quality management system actions like Deviations, OOS, CAPAs, AMS and Change controls using Amplelogic system.
• To follow and ensure data integrity and good documentation practices are implemented in the QC labs.
• Apart from the above, the works assigned by the Head of the department/designee.

Core Competency

• In terms of competency, you are highly oriented with a strong sense of accountability & ownership.
• High on process compliance and implementation skills with strong attention to details.
• Strong communication, interpersonal and problem-solving skills are required.
• Business acumen partnered with a dedication to legality.
• Must be able to manage tasks and priorities and easily adapt to changing situations.
• Highly disciplined and must be organized, self-motivated to learn new learnings and implement them at workplace.
• Must be able to work in a cross-functional environment interacting with other internal and external departments

Qualifications, Key Experiences / Functional Knowledge Requirements: 

• Bachelor’s degree in pharmacy/science.
• Minimum 3-6 years’ experience in the same field.
• Proficient with computer software applications.
• Adhering to cGMP principles and maintaining them effectively.
• Conducting chemical and physical analysis for RM, FP and stability
• Operating various QC equipment and ensuring compliance with GLP, GMP, and safety procedures.