Product Lifecycle Manager - Julphar

Product life cycle: Support the technical aspects of a product during product transfer product troubleshooting and change assessment in accordance with regulatory requirements implement stage 2 (product qualification) based on stage 1 (product development) Improvements/recommendations based on the output of stage 3 (APQR) product remediation in addition to aseptic process simulation and product transport validation.

Main Responsibilities:

• Preparation and review of MSAT product life cycle documents. (i.e. protocols reports etc.)
• Review of product lifecycle related SOPs.
• Handling of EQMS activities like change controls deviations investigation CAPA & audit management Providing the technical inputs related to product life cycle.
• Impart training to product life cycle members continuously.
• Participate in GMP audits and health authorities inspections.
• Review and provide support for regulatory submissions as needed.
• Coordination with project management teams.
• Issuing validation master plan
• Coordinating with different departments & external agencies to ensure the validation objectives are achieved.

Product life cycle:

• Follow up and investigation any product issues like: CAPAs OOS stability issues remediation.
• To provide support for the introduction of new products/SKUs and technology transfer from R&D sites and CMO sites to production sites.
• Process validation aseptic process simulation and holding time study documents.
• Shipping or transport validation documents.

Additional KRAs

• Implementing current Good Manufacturing Practices (cGMP) complying with national and international health authorities requirements for Julphar plants.
• Responsible for the successful transfer of processes into production. Ensure process scalability and manufacturability. In addition the incumbent will coordinate all process relevant major deviations and process adaptations and will be responsible for continuous improvement of the manufacturing processes.
• Contributes to the troubleshooting/remediating and process/product optimization of existing formulations for quality improvement and process optimization.
• Responsible for process validation aseptic process simulation and transport validation protocols and report preparation.
• Collaborate & work closely with both R&D teams and manufacturing sites to enable successful ontime product launches.
• Contributes to the evaluation remediation and optimization of products and processes using statistical tools to ensure safety quality delivery and cost standards.

Core Competency

• In terms of competency you are highly result oriented with a strong sense of accountability & ownership.
• Excellent verbal & written communication skill to convey meaningful insights & information to all key stakeholders.
• Change agile being able to embrace and deliver change and continuous improvement mindset.
• leadership skills and team development capabilities.
• Maintains a high standard of presentation personal integrity and stakeholders support.

Qualifications / Key Experiences / Functional Knowledge Requirements

• Education: MS in Pharmacy Degree is required.
• At least 10 years of relevant leadership experience in the process and technology development for issues that impact manufacturing operations in the pharmaceutical industry including managerial experience and diverse pharmaceutical experience with different dosage forms.
• Advanced knowledge in pharmaceutical production and packaging processes and technologies experience in product formulation and performance; working experience with process technologies manufactured at the site.
• Knowledge of regulatory safety quality validation and documentation requirements for product development commercial production and site transfers