Job Title: QA Digital Manufacturing Lead (Review by Exception &amp; eBR)
Department: QA
Summary:
The QA Digital Manufacturing Lead provides Quality Assurance oversight and guidance for the implementation of
digital manufacturing solutions within a pharma manufacturing environment. The role focuses on enabling review
by exception (RBE), electronic batch records (eBR), and paperless operations, ensuring compliance with
GMP, data integrity, and regulatory expectations while supporting operational efficiency.
Essential Duties and Responsibilities include, but are not limited to, the following:
<ul>
<li>Provide QA leadership and guidance for the design and implementation of eBR and paperless manufacturing processes.</li>
<li>Define and approve review by exception (RBE) strategies, including deviation thresholds, exception handling, and QA review models.</li>
<li>Ensure digital manufacturing solutions are aligned with GMP, data integrity principles (ALCOA+), and applicable regulatory requirements (e.g., FDA, EU).</li>
<li>Partner with Manufacturing, Automation, IT, and Quality teams to embed quality-by-design into digital workflows.</li>
<li>Review and approve quality requirements, risk assessments, and validation/CSA deliverables related todigital plant systems.</li>
<li>Support inspection readiness by ensuring digital processes are defensible, well-governed, and clearly documented.</li>
</ul>
Education and experience:
<ul>
<li>Strong QA background in pharmaceutical manufacturing under GMP.</li>
<li>Hands-on experience with eBR, DeltaV, MES, or digital manufacturing systems.</li>
<li>Solid understanding of review by exception concepts and paperless batch release.</li>
<li>Ability to balance compliance, risk-based thinking, and operational efficiency</li>
</ul>

QA Digital Manufacturing Lead

Job Title: QRM Lead&#150; Digital Core implementation
Department: QA
Prepared On: 30 Apr 2026
Summary:
The QRM lead is responsible for redefining and embedding a risk-based quality management approach for a
new, digitally enabled biologics manufacturing facility. The role ensures that quality risk management is
systematically applied across processes, systems, and operations, with particular focus on operational resiliency,
digital system dependency, and paperless manufacturing continuity.
Essential Duties and Responsibilities include, but are not limited to, the following:
<ul>
<li>Design and implement a modern, facility-wide Quality Risk Management (QRM) framework, aligned</li>
<li>with ICH Q9(R1), supporting a fully digital plant.</li>
<li>Embed risk-based thinking into all aspects of facility startup, including manufacturing processes, digital</li>
<li>systems, automation, data flows, and quality oversight.</li>
<li>Assess and manage risks related to dependency on digital and corporate systems, including DCS, MES,</li>
<li>eBR, ERP, data historians, and network infrastructure.</li>
<li>Define and govern business continuity and contingency strategies to ensure GMP compliance during</li>
<li>system outages (e.g., network failures, cloud unavailability), including controlled fallback for paperless</li>
<li>operations.</li>
<li>Partner with Quality, Manufacturing, IT, Automation, and Engineering to ensure risks are proactively</li>
<li>identified, mitigated, and owned.</li>
<li>Ensure risk decisions are science-based, documented, and inspection-ready, supporting regulatory</li>
<li>confidence in a highly digital operating model.</li>
</ul>
Education and experience: 
<ul>
<li>Extensive experience in Quality Risk Management within GMP-regulated pharma or biologics</li>
<li>manufacturing.</li>
<li>Strong knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations.</li>
<li>Proven ability to operate at a strategic level, influencing site design, operating models, and quality</li>
<li>governance.</li>
<li>Experience addressing operational resiliency, data integrity, and business continuity in digital or</li>
<li>paperless environments.</li>
</ul>

QRM Lead– Digital Core implementation

Process Validation Engineer

Design Assurance Quality Engineer

Job TitleAdministrator / Administrative OfficerJob SummaryThe Administrator is responsible for ensuring the smooth and efficient operation of office activities. They provide administrative support, manage records, coordinate communications, schedule meetings, and assist with day-to-day business operations.Key ResponsibilitiesManage office operations and administrative procedures.Answer phone calls, emails, and other correspondence.Schedule meetings, appointments, and maintain calendars.Prepare, organize, and maintain files, records, and documents.Assist with data entry, report preparation, and document management.Coordinate office supplies and equipment maintenance.Support managers and staff with administrative tasks.Handle incoming and outgoing mail and deliveries.Maintain confidentiality of company information.Assist with travel arrangements and event coordination when required.Qualifications and SkillsHigh school diploma or equivalent; diploma or degree in Business Administration is an advantage.Proven experience in an administrative or office support role.Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).Strong organizational and time-management skills.Excellent written and verbal communication skills.Attention to detail and accuracy.Ability to multitask and work independently.Professional and customer-focused attitude.Preferred Experience1&#8211;3 years of administrative experience.Experience with office management software and databases.Knowledge of record-keeping and filing systems.Working ConditionsTypically office-based.Standard business hours, with occasional overtime as needed.Salary RangeVaries by industry, location, and experience level.Core CompetenciesOrganization and planningCommunicationProblem-solvingTeamworkTime managementConfidentiality and professionalism

Administrator 

We are seeking a highly motivated and experienced R&amp;D professional to contribute to the identification and development of new product ideas and technologies, supporting the growth of our Continence Care business. The successful candidate will leverage their technical expertise to lead or support cross-functional project teams and collaborate effectively across all levels of the organization.Key Responsibilities<ul><li>Translate basic clinical needs into device concepts and prototype development, ensuring compliance with human factors and regulatory requirements.</li><li>Research new technologies and design innovative solutions to enhance the current product portfolio.</li><li>Provide technical support to New Product Development (NPD), Global Marketing, Engineering, and Manufacturing functions.</li><li>Lead or contribute to cross-functional product development teams.</li><li>Manage project schedules, conduct risk analyses, and ensure timely and successful completion of project milestones.</li><li>Prepare financial justifications and reports to support project funding decisions.</li><li>Evaluate vendor product offerings for suitability.</li><li>Source and assess materials and components for use in development activities.</li><li>Evaluate performance and stability of new technologies.</li><li>Support the introduction of new products to the market.</li><li>Conduct trial work to evaluate and validate new technologies.</li><li>Collaborate with patent counsel on patentability assessments and infringement searches, and contribute to patent application preparation.</li></ul>Qualifications &amp; Experience<ul><li>A minimum of 8 years of relevant industry experience, preferably in the medical device sector.</li><li>Bachelor&rsquo;s degree (Honours Level 8) in Biomedical Engineering or a related discipline is required.</li><li>A Master's degree or PhD in a relevant field is preferred.</li><li>Project management experience is an advantage.</li></ul>Key Skills &amp; Competencies<ul><li>Innovative and creative thinker with a proven ability to explore novel concepts and approaches.</li><li>Experience working with medical professionals and translating clinical feedback into product concepts.</li><li>Demonstrated integration of human factors requirements during early-stage development.</li><li>Advanced analytical and problem-solving abilities, including experience with statistical analysis.</li><li>Strong organizational and communication skills.</li><li>Collaborative team player with high levels of enthusiasm and motivation.</li><li>Proficient in Microsoft Office.</li><li>Hands-on experience with product design and prototype development.</li><li>Solid understanding of medical device quality and regulatory standards.</li><li>Familiarity with AutoCAD and 3D modeling software (preferred).</li></ul>

Job Details

QA Digital Manufacturing Lead