Deskripsi Pekerjaan

DESKRIPSI PEKERJAAN

Job Purpose :
Develops, implements and manages Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and qualit
 
Major Accountabilities :
Validation Master Plan
  • Establish, write, maintain Validation Master Plan for process, cleaning and packaging validation.
  • Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process and cleaning procedures.
  • Maintain overview of state of validation at Site and establish the project prioritization across site.
  • Partner with Quality based on feedback (e.g. via division, regulatory inspections, changes in regulations) to establish and maintain common approach and translate that for the site
  • Partner with Engineering and IT to define the process validation/ equipment/systems qualification interface.
  • Develop the strategy for continued process verification (CPV) and annual monitoring batches that ensures all critical process parameters and quality attributes are monitored or analyzed, and actions taken in case of trends or deviations. Reviews risk assessments for CPV.
  • Ensure CPV plans are in place to monitor and trend critical process parameters, quality attributes.
  • Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritisation of activities against the business needs. Reviews risk assessments for validation.
  • Set local procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments.
  • Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities.
 
Validation Activities
  • Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
  • Responsible to translate the critical process parameters and the process control strategy into a focused validation plan for process validation.
  • Author complex validation protocols (e.g. launches, transfers, weak point remediation).
  • Review or author routine re-validation protocols and reports, reviews Master Batch Records (MBRs), associated change controls and supports the execution at the shop floor.
  • Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
  • Support equipment process qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering. Provide input to Quality Manuals (QM)/Quallity Directives (QD)/global Standard Operating Procedures (SOPs) and Technical Guidance Documents (TGDs) to ensure the document is in line with global/local requirements and industry standards.
  • Participate in improvement and remediation of products.
  • Be a senior advisor in case of difficult validation challenges at Site.
  • Understand potential risk areas/shortfalls and make sure that the site validation program is always
 
Requirements :
  • Education (minimum/desirable) : BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent..
  • Languages : Fluent in English and in local language.
  • Relevant Experiences :
    • 8 years experience in manufacturing / manufacturing science and technology / technical development / Quality
    • Thorough understanding of manufacturing processes and related process equipment.
    • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
    • 5 years experience in executing process validation, having led and managed validation projects.
    • Expert in reviewing and writing technical reports.
    • Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
    • Fundamental understanding of standard pharmaceutical analytical testing.
 

Tentang Perusahaan

Why join us

There are many factors that contribute to our success as a global healthcare company, but none is more important than our people. Our company is only as good as the individuals behind it, and only through their knowledge and experience will our company continue to perform and grow. We trust each of our employees to:

Be accountable for their area of responsibility

Deliver superior performance, and

Always raise the bar on the level of performance we strive for.

It is this trust and commitment that drives our growth and success, above all through the superior Performance of our nearly 26 000 employees across more than 140 countries.

 

In return for this drive and dedication, we support each of our employees by maximizing their development and career opportunities at local, regional and global levels.
 
There are many factors that contribute to our success as a global healthcare company, but none is more important than our people. Our company is only as good as the individuals behind it, and only through their knowledge and experience will our company continue to perform and grow. We trust each of our employees to:
Be accountable for their area of responsibilityDeliver superior performance, andAlways raise the bar on the level of performance we strive for.It is this trust and commitment that drives our growth and success, above all through the superior Performance of our nearly 26 000 employees across more than 140 countries. In return for this drive and dedication, we support each of our employees by maximizing their development and career opportunities at local, regional and global levels.
  

Address

Jl Raya Condet Gedong, Pasar Rebo Jakarta Timur 13760 DKI Jakarta

No. Telepon

(021) 8401396

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