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Vacancy description
CNX Therapeutics
Bombay, भारत
Who We Are
At CNX Therapeutics, we’re building a growing European pharmaceutical business with a clear ambition: to improve access to medicines that make a meaningful difference to patients’ lives. With a diverse portfolio and an expanding global footprint, we’re continuing to grow through both our existing business and new opportunities.
Our people are central to this journey. We’re a collaborative, entrepreneurial and fast-moving organisation where individuals have the opportunity to take ownership, make an impact and help shape how we grow. Joining CNX means becoming part of an ambitious team at an exciting stage of our development, with the opportunity to contribute to both our business and the patients we ultimately serve.
The Opportunity
We are looking for an Executive, Quality Assurance to support GMP compliance, supplier assurance and Marketing Authorisation Holder (MAH) oversight across our business.
This is a hands-on, coordination-focused role at the heart of our Pharmaceutical Quality System. You will work closely with the Quality Assurance GMP Manager, colleagues across the company and our external partners, helping to keep our products and suppliers managed in line with company procedures, regulatory requirements and quality objectives.
You'll play a real part in inspection readiness and continuous improvement, and you'll get broad exposure to supplier audits, product quality reviews, stability programmes, product launches and technology transfers.
This is a remote role for someone based in Mumbai. You will be employed through our employment partner on behalf of CNX Therapeutics, and you will work day to day as part of the CNX Quality team.
What You’ll Be Doing
Supporting GMP compliance and MAH oversight activities, so that products and suppliers are managed in line with our procedures and regulatory requirements
Coordinating supplier assurance, including audit scheduling and administration, tracking audit commitments and following up observations, actions and CAPAs
Supporting supplier onboarding, qualification and lifecycle management, making sure the right quality documentation and approvals are in place
Supporting the establishment, maintenance and periodic review of Quality Technical Agreements, and tracking related actions to completion
Coordinating Product Quality Review activities across the portfolio, maintaining schedules, tracking deliverables and following up actions and recommendations
Supporting oversight of Stability Programmes by maintaining tracking tools, monitoring study commitments and coordinating data collection and review
Coordinating, reviewing and maintaining validation documentation, master manufacturing documentation, pharmacopoeial compliance assessments and other product quality records
Supporting the management of GMP quality events, investigations, change controls and supplier-related quality issues, keeping them progressing and closed within agreed timelines
Maintaining schedules, trackers, metrics and performance data to support management review, compliance monitoring and continuous improvement
Supporting improvement initiatives, product launches, technology transfers, acquisitions and cross-functional projects
What We’re Looking For
Essential
A degree in a life science subject (such as pharmacy, chemistry, biology or biochemistry), or equivalent practical experience in pharmaceutical quality assurance
Experience working in a GMP-regulated environment, ideally in quality assurance or a closely related function
A working knowledge of Supplier Assurance and GMP
Excellent attention to detail, with confidence building and maintaining trackers, schedules and metrics (good Excel skills)
Clear written and verbal communication, and the confidence to follow up actions with suppliers and colleagues
Desirable
Exposure to Quality Technical Agreements, Product Quality Reviews and stability programmes
Knowledge of EU/UK GMP guidance, ICH quality guidelines and pharmacopoeial standards
Experience with an electronic quality management system
Audit training, or experience supporting audits
You'll also bring
A methodical approach to problem solving: you gather information carefully, spot risks and help put effective corrective and preventive actions in place
Strong planning and organisation: you juggle multiple priorities and deadlines, follow up proactively and make sure commitments are delivered on time
A collaborative style: you build good working relationships with suppliers, contract service providers and colleagues, and you help promote a culture of quality and continuous improvement
What We Offer
We offer a competitive salary and benefits package in line with local practice and statutory requirements. Full details will be shared during the recruitment process.