Develops and optimizes manufacturing processes for pharmaceutical drug products. Conducts process characterization studies using statistical and risk-based tools. Scales up formulations from laboratory to pilot and commercial manufacturing scale. Develops process validation protocols, reports, and process control strategies. Applies Quality by Design (QbD) principles in process development activities. Identifies critical quality attributes (CQAs) and critical process parameters (CPPs). Uses design of experiments (DoE) to optimize processing conditions systematically. Supports technology transfer by preparing process descriptions and batch records. Investigates manufacturing failures and recommends process improvements. Collaborates with analytical development and QA teams on product development. Prepares CMC sections for ANDA/NDA regulatory submissions. Manages pilot plant and manufacturing scale equipment qualification activities. Stays updated with ICH Q8, Q9, Q10, Q11 guidelines and validation guidance.

Provides overall leadership and accountability for all plant operations. Ensures manufacturing, quality, and EHS compliance at the plant site. Develops plant operating plans aligned with corporate business objectives. Manages P&L, capital expenditure, and operational cost budgets for the plant. Leads regulatory inspections including US-FDA, EU-GMP, and WHO audits. Drives continuous improvement, operational excellence, and lean initiatives. Manages relationships with corporate teams, customers, and regulatory authorities. Oversees talent management, succession planning, and leadership development. Drives technology upgrades, capacity expansions, and new product introductions. Ensures environmental compliance and occupational health and safety standards. Reviews and approves critical quality and operational decisions for the plant. Prepares annual plant performance reviews and presents to senior management. Stays current with industry benchmarks, regulatory changes, and pharma manufacturing trends.

Manages day-to-day manufacturing operations for oral solid dosage forms or injectables. Oversees production planning, scheduling, and adherence to production targets. Ensures GMP compliance across all production activities and areas. Reviews and approves batch manufacturing records and deviation reports. Leads investigation of production failures, deviations, and OOS results. Manages manufacturing team performance, training, and development activities. Coordinates with QA, QC, planning, engineering, and procurement teams. Oversees validation and qualification activities for equipment and processes. Monitors production KPIs and identifies opportunities for efficiency improvement. Prepares capacity utilization reports and production budget management. Manages interactions with regulatory authority inspection teams during audits. Ensures 5S, EHS, and housekeeping standards are maintained consistently. Stays current with GMP regulations, FDA warning letters, and industry best practices.

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.

Evaluates adverse drug reaction reports from multiple data sources globally. Performs benefit-risk assessment for drugs in the company's portfolio. Leads signal detection activities using statistical and qualitative methods. Prepares and reviews Risk Management Plans (RMPs) for regulatory submissions. Manages SUSAR reporting timelines and ensures compliance with global regulations. Supports preparation of PBRER, DSUR, and annual safety reports. Reviews protocols and informed consent forms for safety-related considerations. Maintains pharmacovigilance system master file (PSMF) documentation. Coordinates with global safety team and affiliates on safety communications. Manages safety data exchange agreements with partners and licensees. Conducts pharmacovigilance training for internal and external stakeholders. Supports regulatory authority queries on safety matters for marketed products. Stays current with EMA, FDA, CDSCO pharmacovigilance regulations and guidance.

Collects, processes, and evaluates individual case safety reports (ICSRs). Performs medical coding of adverse events using MedDRA terminology. Prepares and submits expedited and periodic safety reports to authorities. Conducts literature searches for adverse event identification and assessment. Reviews patient narratives for completeness, accuracy, and medical consistency. Manages safety database (Argus, ARISg) and ensures data entry accuracy. Coordinates with clinical, medical affairs, and regulatory teams on safety matters. Prepares Periodic Benefit Risk Evaluation Reports (PBRER/PSUR) per ICH E2C. Supports signal detection and risk management plan activities. Conducts training for field force on adverse event identification and reporting. Assists with preparation for regulatory pharmacovigilance inspections. Manages case reconciliation with CROs, partners, and marketing subsidiaries. Stays updated with ICH E2A-E2F guidelines and CDSCO PV regulations.

Develops and executes the medical affairs strategy for assigned therapy areas. Builds and maintains relationships with key opinion leaders and scientific experts. Reviews and approves promotional materials for medical accuracy and compliance. Responds to medical queries from healthcare professionals and internal teams. Designs and conducts medical education programs, symposia, and advisory boards. Manages publication planning and supports scientific paper publications. Provides medical input for product launches and new indication strategies. Collaborates with clinical, regulatory, and pharmacovigilance teams. Prepares medical information letters and scientific communication materials. Conducts medical training for field force and customer-facing employees. Monitors clinical evidence and prepares medical evidence summaries. Supports health technology assessment and market access activities. Stays updated with clinical guidelines, disease area developments, and evidence.

Manages clinical trial operations across multiple study sites and protocols. Leads a team of CRAs and ensures site monitoring quality and compliance. Reviews monitoring visit reports and escalates critical findings appropriately. Manages CRO relationships and oversees third-party clinical operations. Develops site management plans, monitoring plans, and risk-based monitoring strategies. Coordinates with data management and biostatistics teams for data review. Ensures timely submission of clinical study reports and regulatory filings. Manages study budgets, site payments, and milestone tracking systems. Leads inspection readiness programs for regulatory authority audits. Prepares and delivers training for CRAs on protocols and GCP compliance. Manages trial master file completeness and archival for completed studies. Supports business development by reviewing clinical feasibility for new studies. Stays current with adaptive trial designs, CDSCO regulations, and GCP updates.

Monitors clinical trial sites to ensure compliance with ICH-GCP guidelines. Conducts site initiation visits, routine monitoring visits, and close-out visits. Reviews source documents and case report forms for accuracy and completeness. Identifies and resolves protocol deviations and data discrepancies at sites. Maintains accurate monitoring visit reports and site communication logs. Ensures informed consent process is properly conducted at all study sites. Manages investigational product accountability and temperature records. Coordinates with principal investigators and site staff for study conduct. Tracks patient enrollment and ensures recruitment targets are met on time. Manages trial master file (TMF) and ensures inspection readiness at all times. Supports serious adverse event (SAE) reporting and safety data management. Prepares escalation reports for protocol violations and major deviations. Stays updated with ICH E6 R2, CDSCO CT rules, and regulatory requirements.

Develops and validates analytical methods for drug substances and drug products. Conducts analytical method validation per ICH Q2R1 guidelines. Performs forced degradation studies to identify degradation pathways. Develops stability-indicating methods for all dosage forms. Supports technology transfer of analytical methods to QC laboratories. Operates and maintains HPLC, UPLC, GC, LC-MS/MS, and ICP-MS instruments. Prepares analytical sections of regulatory dossiers and CMC modules. Investigates analytical method failures and out-of-specification results. Collaborates with formulation scientists during preformulation studies. Ensures compliance with data integrity and 21 CFR Part 11 requirements. Manages reference standards and maintains analytical reagent inventory. Supports regulatory inspections with analytical data and laboratory documentation. Stays updated with pharmacopoeial changes, ICH guidelines, and analytical innovation.