QMS Specialist

QMS Specialist

Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

If you are an agile, committed and detail-oriented Quality Specialist, with experience gained in specifically in pharmaceutical Quality Management Systems and Computerized Systems, then we want to hear from you.

Join us to help improve peoples' lives and make healthcare better for everyone

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

We act decisively but we never compromise on quality.We keep our promises and do as we say.We value our heritage and foster an entrepreneurial spirit.We reinvest in our future - in our products, our brands and our people.We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

As QMS Specialist you will support the effective operation, maintenance, and continuous improvement of the global Quality Management System (QMS) within a complex, multi-entity, virtual pharmaceutical business. You will ensure quality compliance across all GxP activities by contributing to the design and implementation of quality systems, monitoring of quality processes, and provision of quality support and oversight across business functions.

Reporting directly to the Associate Director Internal Quality System, our key expectations are a broad understanding and experience of QMS requirements, operation and compliance in a GMP and GDP environment, along with proven experience in the implementation of Computerized Systems (CS). You will act as primary contact for CS compliance and life cycle management, and be expected to bring to the role great organisation skills, good attention to detail, a proactive nature, and be a confident communicator, both within the business and with external partners. You will also be a problem solver with an inquisitive mind and an appetite to develop your technical skills.

The department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities & duties:

Maintain and update controlled quality documents, including SOPs, policies, and templatesSupport and oversee deviation investigations and CAPA lifecycle management, ensuring timely closure and regulatory complianceReview and oversee change control records, supporting impact assessments and coordinating stakeholder input reviewsEnsure that the GxP computerized systems meet the regulatory requirements (Annex 11) - a key deliverable of the roleAct as system administrator for TrackWise Digital EQMS software to support the effective operation of the QMSAdministrate and monitor the GxP training system, maintaining training compliance and recordsParticipate in internal audits and support audit readiness for external audits and regulatory inspectionsCoordinate document and data archiving processes in alignment with data integrity and retention standardsCompile and analyse quality metrics for reporting in QA and Management ReviewsAssist with cross-functional quality risk assessmentsContribute to continuous improvement initiatives and support harmonisation efforts across affiliatesLiaise with cross-functional teams (Regulatory, PV, Supply Chain, Medical Affairs) to support QMS complianceMaintain awareness of relevant GxP requirements (e.g., EU GMP, GDP, ICH, MHRA, Swissmedic) and emerging regulatory expectationsCoordinate and maintain oversight of Product Quality Complaint investigationsOther QA related activities as required to support the department or business

About you:

Candidates with at least two years' experience in a GxP-regulated Quality role, with proven experience in QMS elements and CS implementation within a pharmaceutical MAH or virtual company, should have the skills and experience required for the role. We are also looking for:

Bachelor's degree in life sciences or related degree, or equivalent relevant experienceProven experience in Computerized System implementationPractical experience with QMS elements: document control, deviations/CAPA, change control, training, complaints, audit supportFamiliarity with EU/UK GMP, GDP, Annex 11, and ideally some exposure to Swiss or ICH frameworksExperience in a multi-entity or virtual operating modelExposure to TrackWise, Veeva, or other electronic QMS platformsExperience supporting inspections (MHRA, EMA, Swissmedic, etc.)Involvement in quality metrics and management review reportingStrong attention to detail and organisation skillsAble to work independently and manage competing priorities remotelyProblem-solving mindset with ability to interpret regulations pragmaticallyExcellent verbal and written communicationExcellent IT skills across all MS packages including Excel, Word, PowerPoint, Outlook, TeamsTeam player, comfortable in a global, cross-functional environment

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

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