QC Qualification Engineer - Part-Time

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking a QC Equipment & System Qualification Specialist with expertise in laboratory equipment qualification, including Mass Spectrometry (MS), Fourier Transform Infrared Spectroscopy (FTIR), and other analytical instruments. The ideal candidate will also have a strong understanding of Computer System Validation (CSV) in a regulated environment.

This role is crucial in ensuring that all Quality Control (QC) instruments and computerized systems meet compliance standards and function efficiently within GMP/GxP frameworks.

Key Responsibilities

• Drive and support equipment qualification as per pre-defined timeline.
• Guide and resolve standard issues relating to current processes and systems and qualification and validation approach within and across various functions to ensure all health, safety, quality or training procedures meet requirements.
• Review and collaborate with stakeholders on to identify possible solutions on deviations and/ or project discrepancies.
• Drive QC equipment qualification (Group B and C) with deep knowledge on this project which includes URS, ERES, HLRA, Vendor IOQ, In-House IOQ, PQ, QR etc drafting and execution.
• Change Control management for equipment qualification.
• Drive qualification investigations as and when required.
• Project progressing according to plan and quality expectations.
• Other duties or projects assigned by the manager.
• Comply with all HSE guidelines.
• Detect and report potential accident, risks and propose solutions.
• Participate in HSE risk assessments.
• Responsible for participating in initial training and retraining.

Required Qualifications

• Bachelors or masters degree in chemistry, Analytical Science, Pharmaceutical Science, Engineering, or a related field.
• Experience in laboratory equipment qualification, specifically Mass Spec, FTIR, and other QC analytical instruments.
• Strong knowledge of Computer System Validation (CSV), 21 CFR Part 11, Data Integrity, and GAMP 5 guidelines.
• Familiarity with GMP, GLP, and regulatory requirements for pharmaceutical laboratories.
• Hands-on experience with LIMS, chromatography data systems, and electronic documentation systems is a plus.
• Excellent documentation, communication, and troubleshooting skills.
• Ability to work collaboratively with cross-functional teams, vendors, and regulatory bodies.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.