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Product Lifecycle Manager
4 weeks ago
Productlife cycle: Support the technical aspects of a productduring product transfer product troubleshooting and changeassessment in accordance with regulatory requirements implementstage 2 (product qualification) based on stage 1 (productdevelopment) Improvements/recommendations based on the output ofstage 3 (APQR) product remediation in addition to aseptic processsimulation and product transportvalidation.
MainResponsibilities:
- Preparationand review of MSAT product life cycle documents.(i.e. protocols reports etc.)
- Review of productlifecycle related SOPs.
- Handling of EQMSactivities like change controls deviations investigation CAPA& audit management Providing the technical inputs relatedto product life cycle.
- Impart training toproduct life cycle memberscontinuously.
- Participate in GMP audits andhealth authorities inspections.
- Review andprovide support for regulatory submissions asneeded.
- Coordination with project managementteams.
- Issuing validation master plan
- Coordinating with different departments& external agencies to ensure the validation objectives areachieved.
Product lifecycle:
- Follow up andinvestigation any product issues like: CAPAs OOS stability issuesremediation.
- To provide support for theintroduction of new products/SKUs and technology transfer fromR&D sites and CMO sites to productionsites.
- Process validation aseptic processsimulation and holding time study documents.
- Shipping or transport validationdocuments.
AdditionalKRAs
- Implementing currentGood Manufacturing Practices (cGMP) complying with national andinternational health authorities requirements for Julpharplants.
- Responsible for the successful transferof processes into production. Ensure process scalability andmanufacturability. In addition the incumbent will coordinate allprocess relevant major deviations and process adaptations and willbe responsible for continuous improvement of the manufacturingprocesses.
- Contributes to thetroubleshooting/remediating and process/product optimization ofexisting formulations for quality improvement and processoptimization.
- Responsible for processvalidation aseptic process simulation and transport validationprotocols and report preparation.
- Collaborate& work closely with both R&D teams andmanufacturing sites to enable successful ontime productlaunches.
- Contributes to the evaluationremediation and optimization of products and processes usingstatistical tools to ensure safety quality delivery and coststandards.
CoreCompetency
- In terms ofcompetency you are highly result oriented with a strong sense ofaccountability & ownership.
- Excellentverbal & written communication skill to convey meaningfulinsights & information to all key stakeholders.
- Change agile being able to embrace and deliverchange and continuous improvementmindset.
- leadership skills and team developmentcapabilities.
- Maintains a high standard ofpresentation personal integrity and stakeholderssupport.
Qualifications / Key Experiences /Functional KnowledgeRequirements
- Education: MSin Pharmacy Degree is required.
- At least 10years of relevant leadership experience in the process andtechnology development for issues that impact manufacturingoperations in the pharmaceutical industry including managerialexperience and diverse pharmaceutical experience with differentdosage forms.
- Advanced knowledge inpharmaceutical production and packaging processes and technologiesexperience in product formulation and performance; workingexperience with process technologies manufactured at thesite.
- Knowledge of regulatory safety qualityvalidation and documentation requirements for product developmentcommercial production and sitetransfers
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