Quality Control

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
- Review all QC lab testing documents including chemistry and microbiology testing. For chemistry testing, includes wet chemistry, HPLC, and all physical testing for solid dosage, injection, and semi-solid dosages. For microbiological testing, includes all microbiological testing and sterility testing.
- Review all OOS / OOT investigation report and accident report.
- Manage team of consultants and specialists to deliver mainly analytical test method improvement projects.
- Provide support to QC Analytical Excellence project leaders and other functional project team members, driving the progress of the project(s), including planning, monitoring, and coordinating project activities, and recording/reporting project progress/performance against the project plan.
- Provide project management expertise to project leaders & team members to develop a realistic executable project plan with defined milestones, schedules, budget, and quality plan.
- Direct and manage project development from beginning to end.
- Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.
- Develop full-scale project plans and associated communications documents.
- Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.
- Liaise with project stakeholders on an ongoing basis. Estimate the resources and participants needed to achieve project goals. Draft and submit budge proposals and recommend subsequent budget changes where necessary. Where required, negotiate with other department managers for the acquisition of required personnel from within the company.
- Determine and asses need for additional staff and/or consultants and make the appropriate recruitments if necessary, during project cycle. Set and continually mange project expectations with team members and other stakeholders.
- Delegate tasks and responsibilities to appropriate personnel. Identify and resolve issues and conflicts within the project team. Identify and manage project dependencies and critical path.
- Plan and schedule project timelines and milestones using appropriate tools. Track project milestones and deliverables. Develop and deliver progress reports, proposals, requirements documentations, and presentations.
- Determine the frequency and content of status reports from the project team, analyze results, and troubleshoot problem areas. Proactively manage changes in project scope, identify potential crises, and devise contingency plans.
- Define project success criteria and disseminate them to involved parties throughout project life cycle. Coach, mentor, motivate and supervise project team members and contractors, and influence them to take positive action and accountability for their assigned work. Build, develop, and grow any business relationships vital to the success of the project.

**Requirements**:

- Science, Immunology/Biology - BSc background with minimum of ten (10) years, or MSc with a minimum of seven (7) years, of relevant senior-level experience.
- Project Management Professional (PMP) preferred; other certifications are optional.
- General understanding of manufacturing process, and cGMPs
- Experience and understanding of QC analytical tests will be an asset.
- Skills: QC Analytical Excellence Biological Testing
- Scientist skill set should include:

- Outstanding technical writer (protocols, reports, investigations).
- Familiar with all aspects of Lab Operations.
- Experience in data integrity, test method development and troubleshooting.
- Experience in performing immunology assays (example: ELISAs and cell-based bioassay methods).
- Experienced in conducting scientific investigations, including OOS investigations and CAPAs.
- Experience with FDA 483 remediation an asset.
- Familiar with lab web chemical testing including titration, KF, and other testing.
- Familiar with HPLC/GC testing software: Chromeleon and operations
- Experience of microbiological testing and its documentation
- Experience of reviewing OOS/OOT investigation reports and accident report
- Technical Skills (including various computer programs and systems).
- Outstanding Organization Skills (required to work on multiple projects at the same.

**Why PharmEng Technology?**

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries