Conducts GMP audits of pharmaceutical manufacturing sites and service providers. Prepares audit plans, audit checklists, and audit reports for internal and external audits. Evaluates compliance with Schedule M, WHO-GMP, US-FDA, and EU-GMP standards. Assesses vendor and CMO manufacturing sites for qualification and approval. Identifies GMP deficiencies and works with sites to develop corrective actions. Tracks CAPA commitments and verifies effectiveness of implemented corrections. Supports pre-approval inspection (PAI) readiness at manufacturing sites. Conducts data integrity audits and assesses regulatory compliance risk. Prepares audit dashboards and quality risk management reports for management. Provides GMP guidance and training to manufacturing and quality teams. Participates in regulatory authority inspections as company representative. Manages supplier qualification database and annual audit schedule. Stays current with FDA warning letters, EU inspection findings, and GMP guidance.

Investigates dietary patterns and their relationship to disease outcomes. Designs and conducts population-based nutrition and health studies. Analyzes dietary survey data using epidemiological methods and tools. Develops dietary assessment tools and validates food frequency questionnaires. Collaborates with ICMR, NIN, and national health programs on research. Publishes research on nutrition-disease associations in scientific journals. Contributes to national dietary guidelines and nutrition policy. Manages nutrition surveillance programs and data quality control. Conducts systematic reviews and meta-analyses of nutrition studies. Provides expert opinions on nutrition policy and food regulation. Trains junior researchers on nutritional epidemiology methods. Presents findings at national and international nutrition conferences. Develops health communication messages based on evidence.

Provides comprehensive women's reproductive health and maternity care. Manages normal and high-risk pregnancies with multidisciplinary teams. Performs deliveries including caesarean sections and instrumental deliveries. Diagnoses and treats gynaecological conditions including PCOS and fibroids. Performs laparoscopic and hysteroscopic surgical procedures. Manages menstrual disorders, menopause, and fertility issues. Conducts antenatal and postnatal care and counselling. Performs colposcopy, LEEP, and cervical procedures. Supervises obstetric nursing staff and midwives. Manages obstetric emergencies including PPH and eclampsia. Collaborates with neonatologists for high-risk neonatal management. Participates in women's health audits and quality improvement. Stays current with FOGSI and RCOG clinical guidelines.

Position: Clinical Data Manager We are expanding our team and seek a driven Clinical Data Manager who brings expertise, initiative, and professionalism. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Key Responsibilities: ? Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. ? Contribute to risk management plans, SOPs, and signal detection and evaluation processes. ? Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. ? Conduct structured literature reviews and contribute to scientific summaries and labelling. ? Ensure all cases are coded and processed per MedDRA and applicable global standards. ? Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. ? Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. ? Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Qualifications and Requirements: ? Strong analytical and problem-solving skills with the ability to navigate complex challenges. ? A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. ? Minimum 3?5 years of progressive professional experience in a comparable role. ? Demonstrated proficiency with industry-standard tools, platforms, and methodologies. ? Proven ability to manage competing priorities in a deadline-driven, dynamic environment. ? Excellent verbal and written communication skills; fluency in English is essential. ? 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 Data Manager A dynamic organisation seeks an experienced Clinical Data Manager to take on a multifaceted and impactful role. This is an excellent opportunity for professionals who value structured career advancement and meaningful impact. Role Responsibilities: ? Review source data and ensure completeness, accuracy, and regulatory compliance. ? Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. ? Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. ? Provide clinical site training on data collection standards and regulatory requirements. ? Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. ? Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. ? Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. ? Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Education and Experience Requirements: ? Experience collaborating within cross-functional teams and matrix organisational structures. ? Minimum 3?5 years of progressive professional experience in a comparable role. ? Demonstrated proficiency with industry-standard tools, platforms, and methodologies. ? Proven ability to manage competing priorities in a deadline-driven, dynamic environment. ? High degree of professionalism, integrity, and alignment with organisational values. ? Excellent verbal and written communication skills; fluency in English is essential. ? Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We look forward to welcoming a driven professional who shares our commitment to excellence and sustained impact.