Manages data integrity compliance programs across all GxP computerized systems. Conducts data integrity risk assessments for laboratory and manufacturing systems. Performs data integrity audits and gap assessments per ALCOA+ principles. Develops data integrity SOPs, policies, and training materials. Investigates data integrity incidents and prepares investigation reports. Reviews audit trails, electronic records, and metadata for data integrity. Supports computerized system validation activities related to data integrity. Coordinates with IT on system access controls, backup, and audit trail configuration. Prepares responses to regulatory observations related to data integrity. Tracks and closes data integrity CAPA actions across all departments. Provides data integrity training to QC, production, and support functions. Monitors global regulatory guidance on data integrity and advises quality teams. Stays updated with MHRA, FDA, PICS data integrity guidelines and warning letters.

Operates and monitors pharmaceutical manufacturing equipment and processes. Executes batch manufacturing as per batch manufacturing records and SOPs. Ensures compliance with GMP guidelines during all manufacturing operations. Performs in-process checks and records data accurately in production records. Coordinates with planning team for scheduling batch production activities. Manages housekeeping, cleanliness, and 5S standards in production areas. Reports equipment breakdowns and follows up with engineering for repairs. Assists in process validations and equipment qualification activities. Participates in deviation investigations and CAPA implementation. Ensures proper gowning, hygiene, and personnel behavior in production areas. Monitors material reconciliation and ensures no mix-up or contamination. Conducts line clearance and document checks before each batch production. Stays updated with Schedule M, WHO-GMP, and current GMP guidelines.

Provides critical care nursing to patients in intensive care units. Monitors and manages ventilated patients and hemodynamic support. Administers intravenous medications, vasoactives, and fluid therapy. Operates and troubleshoots ICU equipment including ventilators and monitors. Accurately documents ICU nursing assessments and interventions. Provides family education and emotional support during ICU stay. Collaborates with intensivists and specialists on patient care. Manages central venous lines, arterial lines, and urinary catheters. Recognizes deterioration and responds to medical emergencies promptly. Participates in ICU rounds and multidisciplinary team meetings. Ensures safe and complete nursing handover at shift change. Adheres to infection control and patient safety protocols. Mentors junior nurses and nursing students in ICU care.

Position: Clinical Data Standards Programming Manager (ADaM SDTM) An exceptional opportunity has arisen for a talented Clinical Data Standards Programming Manager (ADaM SDTM) to contribute to our mission. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Duties and Accountabilities: Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Conduct structured literature reviews and contribute to scientific summaries and labelling. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Ensure all cases are coded and processed per MedDRA and applicable global standards. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Key Skills and Qualifications: Recognised qualification in the relevant professional field at the undergraduate or graduate level. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Sound understanding of organisational dynamics and stakeholder management in complex environments. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We are committed to fostering an inclusive workplace and welcome applications from candidates of all backgrounds.

Position: Clinical Manager (RN) We are currently recruiting a results-oriented Clinical Manager (RN) to strengthen our high-performing team. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Key Deliverables and Responsibilities: Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Develop SOPs, work instructions, and training materials for clinical operations teams. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Review source data and ensure completeness, accuracy, and regulatory compliance. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Professional Requirements: Strong communication, presentation, and interpersonal skills across all organisational levels. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. A structured, results-driven approach with the ability to meet defined milestones consistently. Hands-on experience with tools, software, and platforms standard to the profession. Demonstrated teamwork skills and the ability to build trust and rapport across functions. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.