北京招聘

Job Title Packaging Champion
Job Grade
Department MS&T
Reports to (Job Title) Site Head

Job Purpose (State in one sentence the overall objective of the role)

Is responsible for ensuring that packaging (material, sealing, purging, dimensioning and handling) robustly provides the required level 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

Major Accountabilities (Describe the 5-7 main results of the role to be achieved ) (too many results are listed)

? Owns 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 materials, in accordance with the relevant Novartis Pharma TechOps/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 the 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 and Receiving Site
- Purchasing: technical specifications and discussions with packaging material suppliers on new materials, new suppliers, complaints and supplier requirements
- 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 processing issues within the broader MS&T organization (other sites) including TRD. Contributes to 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 packaging 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. Particular attention is to given to the protection of employees, patients, company 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 PU

Key Performance Indicators (Indicate how performance for this role will be measured)

? CpK
? OoS, OoE
? Customer Complaints
? Recalls
? Overdue Deviations
? Success rate of HA's inspections
? Effective CAPAs
? Packaging Yield
? Technology transfers and new product launches on time, right first time
? Technical reports executed on time
? Fulfillment of Validation Master Plans for Packaging
? Weak Product resolution according to plan

Dimensions of the JobJob Dimensions (Indicate key facts and figures)


Number of staff reportingassociates:
? Direct: up to 20, Indirect: up to 40
Financial responsibility
(Budget, Cost, Sales, etc.)
? Operational Budget: up to 3 m
? Contribute to PU financial/business goals
? Minimize rejected batches and write-offs
? Yield improvements
Impact on the organisation ? High, member of Site Leadership Team and Functional Leader of MS&T

Ideal Background (State the preferred education and experience level)

Education (minimum/desirable): ? MSc. In Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology. Or equivalent experience. PhD. Preferred
Languages ? Excellent knowledge of English and proficient in Site local language
Relevant ExperiencesExperience ? Minimum 5 years experience in pharmaceutical formulation, process development, or manufacturing technology
? Minimum IQP Silver certification ( or green Belt or equivalent proficiency in applied statistics) statistic level. Experience in DoE and Gage R&R
? Experience in the packaging technology for pharmaceutical products
? Fundamental understanding of standard pharmaceutical analytical testing

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘