Packaging Lead-Material (Assoc Director)
Location: Suffern New York
Description: Novartis is at present looking to employ Packaging Lead-Material (Assoc Director) right now, this vacancy will be placed in New York. For detail informations about this vacancy opportunity kindly read the description below. Job Purpose:
Is responsible for ensuring that packaging (material, sealing, purging, dimensioning and handling) robustly provides the required lev! el of protection for the products to meet end of shelf-life specifications, while minimizing the impact on the external environment. This role, through packaging risk analyses, appropriate standard-setting and validation, builds the link between the process experts and the technical leaders responsible for proper set-up and reliable/efficient operation of the corresponding equipment. Also, is responsible for introduction of new packaging components with collaboration with site and network experts to enable the site meet future business demand.
Responsibilities:
- Participate in developing and maintaining the site Validation Master Plan for Packaging
- Provides guidance and standards to the Process Units (PUs) in topics related with packaging materials and processing
- Contributes to the standardization of packaging materials and processes across sites
- Continuously reviews and sets appropriate site standards for packaging mat! erials, in accordance with the relevant Novartis Pharma TechOp! s/PharmOps standards (including TRD), in order to leverage improvement opportunities for product protection, quality, safety, patient usability, line efficiency and cost
- Ensures that technical standards for packaging and materials are rigorously applied within the site
- Proposes changes to tooling/equipment, in alignment with changes and/or improvements to packaging materials and processing parameters
- Maintain overview of technological improvements in pharmaceutical packaging internally within Novartis Pharma TechOps/PharmOps, including TRD, as well as the pharmaceutical industry, including material suppliers
- Initiates and manages the qualification activities related to new and changed packaging materials (change control and input to Validation)
- Sets the standards, provides guidance for and reviews risk assessments for packaging changes on site and transfers into the site:
- Ensures the integrity of primary closure after th! e sealing process, including its integrity to provide sufficient protection to meet product requirements
- Suitability of materials in terms of their interaction with the product during the sealing process (leaching, etc.)
- Effect of sealing/packaging on the product (heat, environment, moisture, light, mechanical, vibration, etc.)
- Required conditions for purging of the primary closure, including humidity, oxygen, sterility, etc.
- Handling of the product during charging and feeding (humidity uptake, exposure, breakage, chipping, scaring, etc.)
- Dimensioning of the cavity (head-space) and closure
- Leads projects for more complex and broader packaging changes and shares results with the broader packaging community (other sites) within the MS&T organization
- Interfaces to other activities/departments:
- Transfers in/out: packaging material comparison report (statement of equivalence) between the Giving
- Purchasing: technical specifications and ! discussions with packaging material suppliers on new
- QA: reviews stability reports and participates in audits of packaging material and equipment suppliers
- Global: pro-actively shares knowledge and learnings with respect to packaging materials and
global standard setting
- Supports global projects like Serialization and Product Tracking, Verification Features, etc.
- After escalation from the PU, based upon more complex issues, repeating trends or larger scope of the issue, initiates and performs the investigation of complaints and deviations, either internally within the site or through direct contact with the suppliers
- Reviews and releases regulatory proposals or information required for regulatory filings related to packaging and packagin! g materials
- Represents issues concerning primary closure during inspections and audits and ensures that proper documentation is available to justify choices made
- Owns the Training Curriculum for all associates (operators, technicians, etc.) in primary packaging and provides the necessary training and support to new associates joining
- Ensures proactive product stewardship for packaging within the site and across sites for multi-site products
- Fosters knowledge transfer in packaging among Process Units (PUs) and sites
- Promotes excellence in Packaging within the site, where applicable employing new/modern processes and technologies like Quality by Design (QbD), Design of Experiment (DOE) and Process Analytical Technologies (PAT)
- Ensures adherence to GMP requirements, Guidelines, SOPs, as well as compliance to local laws, the Novartis Code of Conduct, company policies and Health Safety & Environment (HSE) requirements. Partic! ular attention is to given to the protection of employees, patients, co! mpany assets and the environment
- Ensures that both transfer and new product launch will be executed right first time in terms of correct technology match (equipment, materials) and effective handover to the Procuess Unit Minimum requirements •MSc. In Science, Pharmacy or Chemical Engineering Pharmaceutical Technology. Or equivalent experience. PhD. Preferred with 10+ years experiences in pharmaceutical operation, packaging processes, or packaging technology
- Strong Statistical background, IQP Silver certification (or green Belt equivalent) statistic level. Experience in DoE and Gage R&R would be preferable
- Experience in the packaging technology for pharmaceutical products
- Fundamental understanding of standard pharmaceutical analytical testing
- Strong expertise in tech transfer
- .
If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Novartis.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Sun, 04 Aug 2013 07:51:37 GMT