Title: Process Lead - Quality Control
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.
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Job Summary/Main Purpose
The Technical Service Process Lead in the Quality Control division is responsible for maintenance & troubleshooting, documentation team & samples receival. Optimizing quality control processes, ensuring product quality and regulatory compliance, and leading a team of QC professionals at Julphar HQ. This role involves coordinating cross-functional teams, conducting audits, and maintaining adherence to industry standards and cGMP principles, leading QC processes and projects.
Key Responsibilities
- Responsible for overseeing and leading quality control processes and projects within the department, ensuring that products meet quality standards and regulatory requirements. The role involves process optimization, managing QC projects, and coaching and guiding the team.
- Develop, implement, and maintain QC processes to improve efficiency and product quality.
- Analyze current QC processes and propose improvements to optimize performance.
- Coordinate with cross-functional teams, including R&D, regulatory affairs, production, and compliance.
- To manage maintenance/trouble shooting activities for QC related instruments/systems. To manage related communication with the suppliers and the stakeholders.
- To manage documentation team, which is responsible for SOP revision, training, and sample receiving.
- Ensure that all products meet internal and external quality standards.
- Conduct audits and inspections to maintain compliance with regulatory requirements.
- Coach, guide and train QC staff to ensure a high level of competency and motivation.
- Analyze quality data to identify trends and areas for improvement.
- Prepare and present reports on QC activities and project progress to management.
- Ensure adherence to industry regulations and standards (current regulatory & cGMP requirements).
- To adhere with the cGMP principles (premises, personal, equipment, documentation, QMS and audit) and to maintain them in an effective manner.
- To check and ensure proper usage of all the QC equipment.
- To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis.
- 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 and the raw data is checked for correctness, accuracy and compliance.
- To perform investigation for the lab incidents, OOS, OOL results, deviations and take appropriate corrective and preventive actions.
- Follow up &close all the EQMS actions (CAPA, OOS, Deviations, CC)
- To involve and support external and internal audits and to close the audit observations on time.
- 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,
- Excellent communication, interpersonal and presentation skills.
- Technical Competencies: In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan
- Having an Analytical mind with ability to think diversely and understand the big picture, Methodical and diligent with outstanding planning abilities, an analytical mind able to "see" the complexities of procedures and regulations
- Capable of suggesting ideas in a structured manner and having good command on English language.
- High on communication and collaboration, having an ability to manage multiple stakeholders at a time.
- Strong eye for details, having expertise to understand, review and implement the compliance inputs from Quality point of view.
- In-depth knowledge of the industry’s standards and regulations guidelines, excellent knowledge of reporting procedures and record keeping.
- Must be able to manage tasks and priorities and easily adapt to changing situations.
- Ability to create cross functional relations and manage conflicts.
- Problem Solving and high agility on taking right scientific decisions.
Qualifications, Key Experiences / Functional Knowledge Requirements:
- Minimum 7 years of experience in QC/QA department.
- Must be experienced in managing complex and sensitive operational challenges.
- Bachelor’s degree in chemistry or pharmacy
- Proven experience in quality control
- Strong knowledge of regulatory requirements and quality standards relevant to the industry.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong leadership and team management capabilities.
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