Job title: Validation Specialist for an international company - permanent position in Indonesia
Job type: Permanent
Emp type: Full-time
Industry: Pharmaceuticals / Biotech
Expertise: Quality & Compliance
Salary type: Annual
Salary: negotiable
Job published: 2018-12-04
Job ID: 30456
Contact name: Magdalena Chorazy
Phone number: +49 69 348 793 259
Contact email: magdalena.chorazy@hgp.ag

Job Description

Validation Specialist for an international company - permanent position in Indonesia

Location: Indonesia (Southeast Asia)

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, analyse 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 on +4969348 793259 or send your CV to magdalena.chorazy@hgp.ag