Title: Manager - Quality Assurance - Batch Release
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
Job Summary/Main Purpose
To adhere with the cGMP principles and to ensure effective measures taken for Good Documentation practices in Batch Documents.
Responsible for leading Batch review & release, Finished product retention samples and shipping compliance
To ensure the effective measure taken for the good Documentation practiced in the batch documents
Key Responsibilities & Key Result Areas
- Responsible for leading Finished products release and ensure that the activities are performed as per approved procedure
- Responsible for leading the Batch document audit and finished product documents/retain samples checking group and ensure that the activities are performed as per approved procedures and in a timely manner.
- Responsible for leading the Shipping group for final checking of shipment before shipping
- Responsible for training the Batch review team to ensure a robust review process
- Responsible to take UD decision after completion of the complete Batch document review
- Responsible to approve shipment under quarantine forms provided by the Sales/Tender departments as per the approved procedure
- Responsible to communicate with Cross functional departments if any discrepancies found in the batch.
- Responsible for evaluating employee performance as per HR regulations
- To perform any other responsibility assigned by QA – Director / CTO
Core Competency
- Reliability, teamwork
- Problem Solving & Strategic Agility
- Leadership Capability and People Management
- Effective communication Skills
- Decision Taking Capability
- High on accountability and ownership
Qualifications,
Key Experiences / Functional Knowledge Requirements:
- Bachelor/ master’s degree in pharmacy
- Total 10 years’ Experience in pharmaceutical industry
- Quality and sterile manufacturing experience is a must
- Good Computer knowledge and knowledge of QMS system "Agile, Track wise, Amplelogic”.
- Proficient in English.
- Quality and Business decisions taker
- Good Knowledge of cGMP
- Risk assessment knowledge
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