Job Description

We’re on a mission to change the future of
clinical research. At Calyx, we help the
biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but to do this, we need people like you.
Apart from job satisfaction, we can offer you:
HEALTH:

• Medical plan for you and your dependents.
• Personal Accident Insurance
• Life Insurance
• Critical illness cover

WEALTH:

• Salary structure and Flexi basket
• Provident fund of 12%
• Gratuity scheme

YOURSELF: Internal growth and development programs & trainings
Job Purpose:
Reviews and consults on standard operating procedures and associated documents. Processes quality incidents including performing root cause analysis. Hosts sponsor and internal audits.
Defines adopt and oversees quality & compliance to processes and standards as fundamental to technology enables services. Provides expertise for solution development & computerized system validation. Collaborates with the business partners to monitor, identify and implement continuous process improvement across all service areas.
Key Accountabilities:
Review SOPs for Quality Excellence & Compliance :

• Train & Advise internal stakeholders in creating & updating Standard Operating Procedures
• Review Standard Operating Procedure for adherence to regulatory and critical quality criteria
• Maintain and safeguard the integrity of the quality management system as a whole
• Release Standard Operating Procedures and associated document
• Maintain an inventory of Standard Operating Procedures including their history

Provide Regulatory Expertise & Training:

• Schedule and deliver regulatory training sessions
• Monitor for training compliance, up-to-date Curriculum Vitae, and s
• Ensure that the organization has relevant regulatory expertise proven by personal and quality records.

Review & Assess Suppliers:

• Establish standards and critical quality criteria for supplier evaluations
• Prepare assessment/audits plans for suppliers’ product/services
• Coordinate with supplier representative & internal stakeholders’ scope, timing, and logistics of review/audit
• Conduct supplier audits/assessments following a risk-based approach
• Communicate & report on outcomes to management, internal stakeholders & supplier
• Oversee remediation plans provided by the supplier in conjunction with internal stakeholders.

Oversee and Consult on Quality of Service & Technology Deliverables:

• Engage in clinical trial and technology projects to oversee deliverables for meeting critical quality criteria
• Provides training, guidance, consultation, and overall quality expertise in support of clinical trial and technology validation activities
• Oversee and support changes to ensure the integrity of clinical trial activities, technology, and overall inspection readiness
• Consult on controls for patient safety and data integrity as part of clinical trial and/or solution design
• Review risks and oversee mitigations for completion and effectiveness
• Verify and initiate interventions to safeguard that quality excellence and GxP compliance is achieved.

Manage Quality Incidents & CAPAs including Effectiveness Review:

• Evaluate suspected quality incidents and confirm the severity
• Support and monitor the definition completion of corrections
• Coordinate analysis and definition of problem statements including engagement with key stakeholders
• Train and supervise the root cause analysis efforts & derive corrective and preventative actions.
• Perform effectiveness checks and ensure controls of periodic review
• Establish transparency for quality incidents with customers and internal stakeholders.

Ensure Security & Business Continuity Controls

• Liaise with security subject matter experts and ensure involvement in project and incident reviews
• Review and advise on business continuity and service/data resilience controls
• Verify business continuity and disaster recovery plans for being effective and exercised.

Host & Leads Sponsor Audits and Inspection

• Coordinate with customer representative scope, timing, and logistics
• Prepare agenda and teams to best represent services and technologies reviewed
• Represent companies’ quality management system and quality standards & Moderate and oversee sessions with customer representatives
• Maintain control over requests and their timely completion & Obtain feedback proactively during sessions and as part of the closeout
• Coordinate audit response collection and review for effectiveness & Monitor completion of commitments provided as part of responses
• Confirm with customer successful closure and remediation of addressed concerns.

Plan for Internal Auditing / Assessments including Suppliers

• Define an approach to internal auditing and derive audit program/plans for services and technology solutions
• Prepare audit conduct in coordination with the audit sponsor's agenda, logistics, and scope.
• Complete audit documentation including reviewed procedures, practices, evidence, and interview summaries.
• Provide feedback during the session and as part of the closeout
• Report and communicate audit outcomes to audit sponsors and relevant stakeholders.
• Create audit reports and obtain audit responses for raised observations.
• Monitor action plans through to completion.

Enable Continuous Improvement Framework and Arrange for Management Review :

• Keep an open mind for improvement opportunities and encourage improvement initiatives
• Review quality and operational information systems and inform quality forums
• Develop actions plan to reduce variations and defects to achieve predictable outcomes
• Promote a quality culture that applies a systematic approach to human fallibility.

Skills:

• Experience in quality and compliance as it pertains to technology-enabled services (preferable in the pharmaceutical / clinical research industry)
• Profound Knowledge of elements of a quality management system and continuous improvement methodologies.
• Excellent interpersonal, verbal and written communication skills
• Highly motivated and seeks opportunities for development
• Exhibits a sense of urgency when addressing problems and ensures completion of commitment.
• Culturally aware and able to think and work globally.
• Intermediate desktop software skills (MS Office, Excel, Adobe PDF, etc.).
• Effectively communicate issues, along with potential recommendations, to various functional groups.
• Work professionally with highly confidential information.
• Work independently and consistently in a fast-paced environment.

Knowledge and Experience:

• Clinical trials and/or research work experience preferred, with emphasis on GCP and technology compliance.
• Familiar with services and solutions as it relates to clinical trial activities i.e. clinical trial management, medical imaging, randomization, and trial supply management, clinical data management, and/or regulatory information management
• Experience in advising project teams from a quality and GxP compliance perspective
• Experience in quality management system maintenance, risk management, auditing, and/or computerized system.

Education:

• Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification
• Postgraduate degree in a science, technology, or industry-related discipline preferred.

Come as you are.
We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.