- Skills Required: Quality Assurance, Quality Management Systems, Deviations and CAPAs, GDP, Risk Assessments
- Industry: Pharmaceuticals
- Location: Mumbai City, Maharashtra, India
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 templates
- Support and oversee deviation investigations and CAPA lifecycle management, ensuring timely closure and regulatory compliance
- Review and oversee change control records, supporting impact assessments and coordinating stakeholder input reviews
- Ensure that the GxP computerized systems meet the regulatory requirements (Annex 11) - a key deliverable of the role
- Act as system administrator for TrackWise Digital EQMS software to support the effective operation of the QMS
- Administrate and monitor the GxP training system, maintaining training compliance and records
- Participate in internal audits and support audit readiness for external audits and regulatory inspections
- Coordinate document and data archiving processes in alignment with data integrity and retention standards
- Compile and analyse quality metrics for reporting in QA and Management Reviews
- Assist with cross-functional quality risk assessments
- Contribute to continuous improvement initiatives and support harmonisation efforts across affiliates
- Liaise with cross-functional teams (Regulatory, PV, Supply Chain, Medical Affairs) to support QMS compliance
- Maintain awareness of relevant GxP requirements (e.g., EU GMP, GDP, ICH, MHRA, Swissmedic) and emerging regulatory expectations
- Coordinate and maintain oversight of Product Quality Complaint investigations
- Other 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:
- Bachelors degree in life sciences or related degree, or equivalent relevant experience
- Proven experience in Computerized System implementation
- Practical experience with QMS elements: document control, deviations/CAPA, change control, training, complaints, audit support
- Familiarity with EU/UK GMP, GDP, Annex 11, and ideally some exposure to Swiss or ICH frameworks
- Experience in a multi-entity or virtual operating model
- Exposure to TrackWise, Veeva, or other electronic QMS platforms
- Experience supporting inspections (MHRA, EMA, Swissmedic, etc.)
- Involvement in quality metrics and management review reporting
- Strong attention to detail and organisation skills
- Able to work independently and manage competing priorities remotely
- Problem-solving mindset with ability to interpret regulations pragmatically
- Excellent verbal and written communication
- Excellent IT skills across all MS packages including Excel, Word, PowerPoint, Outlook, Teams
- Team 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.
By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.
Get in Touch
If you would like to know more about Ortolan People and how we can help you reduce your ongoing recruitment costs, get in touch!
Or call
020 3743 0600
I have worked with Ortolan for over 6 years now and throughout that time they have been unfailingly professional, responsive and a real partner to our business. I would have no hesitation in recommending their services.
