Senior / Validation Consultant

Southeast Asia (Indonesia, Singapore)
3. December 2018

Job description

Location: Southeast Asia (Indonesia, Singapore)

HGP Asia, a company of the HGP global consulting group, is seeking for experienced validation consultants within the Regulatory Compliance unit for the participation in the various projects in the area of Life Science. HGP Asia provides business consultancy services for all aspects of Manufacturing Operations Management for the Pharma, Medical Device, Biotech and related industries.

Your tasks:

As a validation consultant, you will play a leading role in validation, compliance and quality activities at our client’s site. The activities focus primarily on advising and assisting our clients with complex challenges. Therefore, you will take the lead in the implementation of solutions, put forward by you, at an organisational and strategic level.

Responsibilities include:

  • Develop risk assessment, system impact assessments, validation plans, protocols and reports.
  • Review, analyze and interpret system performance data for completed validation.
  • Prepare final report packages by summarizing the data.
  • Perform validation, commissioning and qualification of pharmaceutical and biopharmaceutical equipment
  • Investigate deviations, write investigation reports and create summary reports.
  • Promote cGMP and regulatory compliance into assigned projects.

Our requirements:

  • Degree (or similar) in IT, Engineering or Science
  • 3+ years’ experience working in validation, quality systems, operations, engineering or any combination thereof.
  • Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge is a must have.
  • Validation experience using risk-based approach (FMEA, PHA, etc).
  • Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, commissioning, I/OQ protocols, etc) guidelines, international regulatory requirements and standards and other in.
  • Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.

What we offer:

  • Consulting roles for international Pharma and Life Science clients in strategically relevant projects.
  • Work in a professional consultancy environment within a highly motivated team.
  • The opportunity to take on responsibility and to help shape our organization.
  • Excellent career development and growth opportunities.

Who we are

Halfmann Goetsch Partner AG are a business consultancy specializing in Life Sciences. We are global partners for Digital Transformation and Compliance in the pharmaceutical industry. Our consultancy services include Information Risk Management, Data Privacy (GDPR), Data Integrity, Computer System Validation (CSV), MES, GMP, Serialization and Audit Readiness.

HGP is based in Switzerland, with regional headquarters in Germany (Frankfurt), Singapore and Indonesia as well as a recruitment branch, HGP Life Path. Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out global projects with the necessary expertise and presence.

Our clients are global corporations, small and medium enterprises, manufacturers and suppliers in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices, manufacturers of packaging machinery, processing equipment and software providers for the pharmaceutical industry.

www.hgp.ag

If you are interested, please contact Magdalena Chorazy, Recruitment Consultant in HGP Asia. You can call me her +49 69348 793259 or send your CV to magdalena.chorazy@hgp.ag

Application form

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    I hereby confirm that I have a valid work permit for the work site chosen.
    • I hereby agree to HGP AG storing my data as part of the application process.
    • In the event that the application is unsuccessful, HGP AG shall store the data for a further 24 months. This enables them to contact the candidate in the event that another position becomes available or if they have any questions.
    • After a period of 24 months has expired all data except the name, date of birth and the level reached in the application process shall be deleted. These items of data can be stored for a further 2 years, after which time they shall be deleted.
    • Every candidate is entitled to request that HGP AG delete all of his or her data at any time.

Apply now

Halfmann Goetsch Partner AG
St. Alban-Vorstadt 94
CH-4052 Basel
jobs@hgp.ag

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