Manager- Quality OSD Value Stream

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.

To ensure end-to-end Quality Assurance oversight across pharmaceutical manufacturing sites, act as Qualified Person (QP) for batch certification and release, and lead product lifecycle management activities in compliance with cGMP, regulatory requirements, and company quality standards.

To ensure cGMP compliance in the related pharmaceutical manufacturing plants by monitoring:

• Good Documentation Practices.
• Correctness of batch documents, logbooks, labels, etc.
• Gowning attire.
• Cleanliness.
• Compliance with environmental conditions of all classified areas.
• Ensuring all equipment is used in a calibrated and qualified state.
• Adherence to SOPs, manufacturing and packaging instructions.
• All end-to-end activities in the manufacturing plants.

Review and approve manufacturing operations-related deviation investigations and product quality-related investigations, including:

• Deviations
• Complaints
• Recalls

Ensure timely completion of investigations and assessments in Ample Logic.

Review and approve CAPA for related plants in Ample Logic and ensure proper implementation.

Review and approve change controls and related assessments for products/plants in Ample Logic.

Perform regular site inspections.

• Monitor self-inspections.
• Monitor GMP inspection CAPA compliance.

Responsible for implementing the Quality Improvement Plan at the respective site.

• Coordinate with cross-functional teams (CFTs) to establish and spread the Quality Culture.

• BMR – Batch Manufacturing Record
• BPR – Batch Packaging Record

• Technology Transfer
• Process Validation (PPQ)
• Commercial Manufacturing
• Continued Process Verification (CPV)
• Product Discontinuation

• APQR / PQR trends
• Ongoing stability programs
• Lifecycle risk assessments
• Continuous improvement initiatives based on lifecycle data
• Technical & GMP Documentation

Review all technical department SOPs for adequacy of procedure contents, risk assessments, and other GMP documents from a quality perspective.

• People Development & Batch Document Audit
• Identify, develop, and train successors for the role, if needed.
• Coach others in the area of expertise.
• Ensure other functions, such as Operations, have sufficient product knowledge and understanding to execute their roles.
• Lead batch document audits.
• Lead retention sample checking.
• Ensure timely and compliant execution as per approved procedures.

Supervise final checks of shipments before dispatch, ensuring all procedures are followed, including approvals of shipments under quarantine as per Sales/Tender department requirements.

Develop and deliver training programs to enhance team capabilities and knowledge of:

• Batch release
• Documentation
• Compliance standards
• Audit Readiness

Ensure all batch release documentation and processes are audit-ready for both internal and external audits.

Make the final "Usage Decision" (UD) following a thorough review of the complete batch documentation.

Act as the primary contact for compliance-related communications, addressing discrepancies and collaborating with cross-functional teams.

Proactively address batch-related compliance issues and provide solutions to prevent recurrence.

Focus on achieving compliance and batch release goals with strong ownership and accountability.

Responsible for QA Operations KPI adherence and timely reporting for the respective site.

Effectively manage multiple batch release priorities in a fast-paced and dynamic environment.

Review…