Validation CQV Project Lead (Content Expert)
DPS Group Global
Singapore, Singapore, SG
4d ago
source : BidRecruit Ltd.

DPS is a leading Project Management and Engineering Company delivering Full-Service Engineering with a client first™ mentality and personal touch across a range of market sectors : Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up.

We have one goal : to deliver more than our clients expect first time, every time. We™ve been serving industry around the world for over 45 years, relied on for our agility, original thinking, sound judgment and high-calibre people.

What sets us apart is the rapport we build with our clients and the care we take to gain a fundamental understanding of our client™s businesses.

We employ over 1600+ people out of our fifteen office locations and we serve a broad range of clients ranging from multinational companies to small generic producers.

What are we looking for?

DPS has an excellent opportunity for a highly motivated and ambitious Validation CQV Project Lead (Content Expert) to work out of our multidiscipline contract services operation in Singapore.

Our Contract Services operation has a successful track record of customizing our services to deliver sector-specific technical expertise to life sciences and advanced technology customers worldwide.

We build integrated solutions tailored to client™s specific needs, which includes providing individual resources and delivering flexible solutions through diverse scope of work.

The Validation CQV Project Lead (Content Expert) to work with a Biopharma client in Singapore. Ideal candidates should have previous experience devising and implementing process and equipment validation strategy and authoring site validation master plans within cGMP capital project settings.

This position will be expected to work in our client™s site across Singapore Island.

Job Scope :

  • Responsible for delivering compliant documentation covering IQ / OQ and PQ as necessary as well as working with multi-disciplinary client and project team members to ensure the design, installation, commissioning and qualification of equipment, systems, and processes is conducted according to established quality and regulatory standards.
  • Analyse and resolve issues and provide guidance in delivery of Qualification / Validation services.
  • Develop / review all technical documentation and reports pertaining to systems and processes pertaining but not limited to : Design Qualification (DQ), Impact Assessments / Analysis (System and Component Level), Installation / Operational and Performance Qualification (IQ / OQ / PQ), etc.
  • Adopt and incorporate the DPS C&Q methodology, tools, know-how and value proposition in the delivery of projects to Singapore clients.
  • Provide technical project leadership for a major capital expansion project.
  • Provide oversight in regard to project plans, scopes of work and related documents.
  • Will be involved in cross-functional agreement on best Engineering and C&Q approaches that are fit-for-purpose with consideration given to risk management, cost, and schedule.
  • Develop the CQV / Quality Schedule and associated deliverables associated with the project.
  • Work with Internal Project Team to determine the required internal structures and resource loading associated with the project from Planning through Implementation.
  • Generation / approval of a Project Validation plan to outline the project execution strategy plan.
  • Assist in the support and management of external vendor services.
  • Provide senior level technical support to staff / management on project activities as needed.
  • Job Requirements :

  • Bachelor™s Degree in Science or related technical field.
  • Must have 8+ years of IQ, OQ, PQ qualification experience in a pharmaceutical environment.
  • Significant experience of leading C&Q teams in the pharmaceutical industry including bio-pharmaceutical and utility qualification activities and documentation requirements.
  • Must have strong cGMP and GDP experience as well as capital project knowledge.
  • General exposure and experience in a GMP / Validation discipline with a knowledge and understanding of pharmaceutical Design / Construction / Commission / Validate processes and how they relate to regulatory requirements and GMP regulations such as E.U. EMA and U.S. FDA.
  • Must have a knowledge on ICH guideline Q9 on quality risk management.
  • Excellent communication & presentation skills, ability to influence, persuade, negotiate and compromise, lead and chair discussion.
  • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
  • Must have strong, hands-on abilities as well as project management expertise.
  • Ability to lead but also plan, execute, and document projects independently.
  • Next Step :

    Prepare your updated resume (please include your current / last salary package with full breakdown such as base, incentives, annual wage supplement, etc.

    expected package and your notice period.

    All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.

    Recruitment Agencies : Please do not reply to this job advert.

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