Product Lifecycle Manager

at  Julphar

Description:
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.

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

• 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.