Salary Between 15-20 Lacs Manufacturing Oversight: Review and approve executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements. Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release. Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site. Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards. Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams. Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance. Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting. Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, and review CAPA closure documentation to confirm adequacy of evidence. Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures. Ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements. Participate in virtual inspections and audits, providing requested documentation and clarifications. Maintain close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues. Provide remote guidance to manufacturing site teams through virtual meetings, calls, and written communication. Key Skills and Competencies: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques. Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.). Strong analytical and problem-solving skills. Effective communication and documentation skills. Ability to manage cross-functional teams and prioritize tasks. Proficiency in QMS tools and software. Education and Qualifications: Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.
Salary Between 15-20 Lacs QA-Validation – Sterile Injectables (Candidate with B1/B2 USA Visa Preferred) Experience Required: 10-15 years Location: Remote Department: Quality Assurance No. of vacancy: 01 Key Responsibility: Validation Activities: Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity. Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site. Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements. Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment. Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented. Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation. Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover. Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality. Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs Key Skills and Competencies: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques. Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.). Strong analytical and problem-solving skills. Effective communication and documentation skills. Ability to manage cross-functional teams and prioritize tasks. Proficiency in QMS tools and software. Education and Qualifications: Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.
QA-Compliance – Sterile Injectables Experience Required: 10-15 years Location: Remote Department: Quality Assurance No. of vacancy: 01 Key Responsibility: Prepare and review QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes. Review, approve, and trend Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance. Handle deviations by reviewing deviation reports, assessing adequacy of root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements. Review, approve, and trend deviations for recurrence patterns and systemic issues; prepare periodic deviation trend analysis reports for management. Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines. Review and approve investigation reports for OOS (Out-of-Specification), OOT (Out-of-Trend), and any critical quality incidents, ensuring accuracy, completeness, and regulatory compliance. Conduct remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable regulatory requirements. Manage vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits (virtual or on-site as required), and review of vendor audit reports. Handle vendor quality notifications and change notifications by reviewing the impact on processes, products, and regulatory compliance, and coordinating required actions with relevant departments. Support and participate in virtual internal and external audits, providing requested documentation, clarifications, and evidence. Monitor and trend QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics) and prepare quarterly quality performance reports for management. Key Skills and Competencies: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques. Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.). Strong analytical and problem-solving skills. Effective communication and documentation skills. Ability to manage cross-functional teams and prioritize tasks. Proficiency in QMS tools and software. Education and Qualifications: Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.
Salary Between 15-20 Lacs QA-Validation Sterile Injectables (Candidate with B1/B2 USA Visa Preferred) Experience Required: 10-15 years Location: Remote Department: Quality Assurance No. of vacancy: 01 Key Responsibility: Validation Activities: Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity. Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade AD) based on environmental monitoring and qualification data from the site. Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements. Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment. Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented. Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation. Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover. Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality. Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs Key Skills and Competencies: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques. Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.). Strong analytical and problem-solving skills. Effective communication and documentation skills. Ability to manage cross-functional teams and prioritize tasks. Proficiency in QMS tools and software. Education and Qualifications: Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
Job Title: Engineering Documentation Specialist – Sterile Injectable Facility (Remote – India) Department: Engineering / Technical Operations Reports To: Associate Director of Engineering / Director of Engineering (U.S.) Location: Remote (India) – Supporting U.S.-based pharmaceutical injectable manufacturing facilities Position Overview: The Engineering Documentation Specialist will be responsible for creating, maintaining, and managing all engineering-related documentation for sterile injectable manufacturing facilities operating under FDA 503B or cGMP environments. This position plays a critical role in ensuring technical accuracy, regulatory compliance, and timely documentation of engineering activities, investigations, and quality actions. The ideal candidate will have a solid understanding of pharmaceutical engineering systems, equipment qualification, utilities, and regulatory documentation practices. Key Responsibilities: 1. Documentation & SOP Management • Draft, revise, and maintain Standard Operating Procedures (SOPs) related to engineering, maintenance, calibration, and utilities. • Ensure all documentation meets FDA, cGMP, and company quality standards. • Manage document change requests, track approvals, and ensure controlled document distribution. 2. Engineering Event Documentation • Prepare breakdown preliminary investigation reports, work carried out summaries, and detailed root cause analyses (RCA). • Utilize 5-Why, Fishbone, and Pareto tools for structured problem-solving and investigation. • Coordinate with U.S.-based engineering staff for accurate technical inputs and documentation updates. 3. Deviation & Change Management • Draft and document engineering-related deviations, perform investigation summaries, and recommend corrective and preventive actions. • Initiate and draft Change Controls, including justification, impact assessment, risk analysis, and implementation documentation. • Conduct risk assessments (FMEA/RA templates) and ensure alignment with Quality Management System (QMS) expectations. 4. Project Documentation Support • Prepare User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and related technical documents for new equipment, systems, or modifications. • Coordinate with vendors and internal stakeholders for technical data collection and documentation consistency. 5. Quality & Compliance Tracking • Maintain and update CAPA trackers, ensuring timely follow-up and closure of all engineering-related actions. • Track and monitor QMC (Quality Management Committee) action items; ensure all commitments are addressed and closed before deadlines. • Support in internal and external audit documentation readiness. 6. Reporting & Presentation Support • Prepare and update Engineering MIS (Management Information System) presentations and dashboards for monthly reporting. • Prepare QMR (Quality Management Review) engineering sections, including performance metrics, deviation trends, and CAPA status. • Support management in compiling data for KPI tracking, continuous improvement, and regulatory compliance metrics. 7. Communication & Coordination • Work closely with U.S.-based Engineering, Quality, and Validation teams via email, calls, and virtual meetings. • Follow up with cross-functional teams (Maintenance, Validation, Quality, and Projects) to gather inputs for timely document completion. • Ensure consistency and traceability between engineering actions and QMS documentation. Qualifications and Experience: • Bachelor’s Degree in Mechanical, Electrical, Instrumentation, Chemical, or Industrial Engineering (preferred). • 3–8 years of experience in engineering documentation or technical writing within a pharmaceutical / sterile / injectable / 503B environment. • Solid understanding of GMP, cGMP, 21 CFR Part 210/211, and 503B guidance. • Experience with deviation, CAPA, and change control systems (TrackWise, MasterControl, or similar). • Proficient in root cause analysis tools, risk assessment methodologies (FMEA, 5-Why, Fishbone), and compliance documentation. • Strong proficiency in MS Office (Word, Excel, PowerPoint, Outlook). • Excellent technical writing, analytical, and communication skills. Key Competencies: • Strong attention to detail and documentation accuracy. • Ability to interpret engineering drawings, maintenance logs, and system reports. • Familiar with HVAC, cleanroom systems, purified water, WFI, nitrogen, and compressed air utilities. • Proactive follow-up and task closure discipline. • Comfortable working independently with remote U.S. engineering leadership. • Ability to manage multiple documentation tasks under tight timelines. Preferred Skills: • Experience in equipment qualification or validation documentation is a plus. • Exposure to audit and compliance documentation for FDA-regulated environments. • Experience in MS Power BI or dashboard creation for MIS/QMR reporting. Work Schedule: • Flexible remote work hours aligned partially with U.S. time zones (Arizona/PST) for coordination.
Location: Remote Department: Human Resources Company: Medivant Healthcare Reports To: HR Manager /Associate Director – HR Salary: 06-07 LPA About Medivant Healthcare Medivant Healthcare is a rapidly growing U.S.-based pharmaceutical manufacturing company with a strong focus on quality, compliance, and innovation. Our mission is to deliver high-quality, affordable injectable medications that improve patient outcomes. With operations across the U.S. and India, we pride ourselves on maintaining global standards in every aspect of our work. About the Role We are seeking an experienced HR Recruiter with proven expertise in both U.S. and India hiring . The ideal candidate will have a strong understanding of end-to-end recruitment processes, compliance requirements, and market practices across both regions. Prior experience in pharmaceutical or healthcare industry hiring will be a strong advantage. Key Responsibilities Manage the full recruitment lifecycle – from job posting, sourcing, screening, interviewing, and selection to onboarding. Handle recruitment for both U.S. and India-based positions , ensuring compliance with local labor laws and organizational standards. Source and attract top talent through multiple channels including job portals, LinkedIn, referrals, and networking. Partner with hiring managers to understand staffing needs and develop tailored recruitment strategies. Coordinate interview schedules, feedback collection, and candidate communication in a timely and professional manner. Maintain candidate data and recruitment metrics in the Applicant Tracking System (ATS) Like ADP, Paylocity and GreytHR Support employer branding initiatives and enhance candidate experience across regions. Work closely with HR and Operations teams for smooth onboarding and documentation. Ensure adherence to company policies and equal employment opportunity standards. Requirements Bachelor’s degree in Human Resources, Business Administration, or related field. 5+ years of recruitment experience , including minimum 2 years in U.S. hiring and India hiring exposure. Experience in pharma, healthcare, or life sciences recruitment preferred. Strong understanding of sourcing strategies, job boards, and networking techniques. Excellent communication and interpersonal skills. Ability to work across time zones and handle multiple requisitions effectively. Proficiency in MS Office and ATS platforms.
Job Title: Sales Consultant Location: Remote Company: Medivant Healthcare Experience Required: 58 years Employment Type: Full-Time Salary : 9 to 12 LPA About Medivant Healthcare: Medivant Healthcare is a U.S.-based 50B pharmaceutical manufacturing company specializing in high-quality generic injectable medications. With a strong commitment to quality, compliance, and accessibility, we work closely with hospitals, clinics, and pharmacies across the United States to meet their healthcare needs efficiently and reliably. Position Overview: We are seeking a dynamic and self-driven Sales Consultant with prior experience in B2B pharmaceutical sales and a proven record of working with U.S. clients . This is an independent role requiring the candidate to actively engage in cold calling, outbound calling, and email outreach to generate and manage leads. The role also involves coordinating with clinics and pharmacies in the U.S. and effectively demonstrating our product portfolio to prospective customers. Key Responsibilities: Independently manage the end-to-end sales process from lead generation to closing. Conduct cold calls, Outbound calls, and email campaigns to identify, qualify, and nurture potential clients. Coordinate with clinics, hospitals, and pharmacies across the U.S. to introduce and promote Medivant's product portfolio. Conduct product demonstrations and presentations to explain product features, benefits, and clinical relevance. Build and maintain long-term relationships with healthcare professionals, purchasing managers, and decision-makers. Collaborate with internal teams (Regulatory, Operations, and Finance) to ensure smooth onboarding and order fulfilment. Track leads, maintain CRM data, and provide regular sales reports and insights. Stay informed about market trends, competitor activities, and emerging opportunities in the pharmaceutical sector. Qualifications & Skills: Bachelor's degree in Pharmacy, Life Sciences, Business Administration, or a related field (MBA preferred). 58 years of experience in B2B sales , preferably in the pharmaceutical or healthcare industry . Proven experience working with U.S.-based clients is mandatory. Strong experience in cold calling, lead generation, and client presentations . Excellent communication and interpersonal skills with the ability to influence decision-makers. Confident in conducting virtual meetings and product demonstrations with U.S. clients. Self-motivated, organized, and capable of working independently with minimal supervision. Proficiency in CRM tools and MS Office Suite.
Location: Remote Department: Human Resources Company: Medivant Healthcare Reports To: HR Manager /Associate Director HR Salary: 06-07 LPA About Medivant Healthcare Medivant Healthcare is a rapidly growing U.S.-based pharmaceutical manufacturing company with a strong focus on quality, compliance, and innovation. Our mission is to deliver high-quality, affordable injectable medications that improve patient outcomes. With operations across the U.S. and India, we pride ourselves on maintaining global standards in every aspect of our work. About the Role We are seeking an experienced HR Recruiter with proven expertise in both U.S. and India hiring . The ideal candidate will have a strong understanding of end-to-end recruitment processes, compliance requirements, and market practices across both regions. Prior experience in pharmaceutical or healthcare industry hiring will be a strong advantage. Key Responsibilities Manage the full recruitment lifecycle from job posting, sourcing, screening, interviewing, and selection to onboarding. Handle recruitment for both U.S. and India-based positions , ensuring compliance with local labor laws and organizational standards. Source and attract top talent through multiple channels including job portals, LinkedIn, referrals, and networking. Partner with hiring managers to understand staffing needs and develop tailored recruitment strategies. Coordinate interview schedules, feedback collection, and candidate communication in a timely and professional manner. Maintain candidate data and recruitment metrics in the Applicant Tracking System (ATS) Like ADP, Paylocity and GreytHR Support employer branding initiatives and enhance candidate experience across regions. Work closely with HR and Operations teams for smooth onboarding and documentation. Ensure adherence to company policies and equal employment opportunity standards. Requirements Bachelor's degree in Human Resources, Business Administration, or related field. 5+ years of recruitment experience , including minimum 2 years in U.S. hiring and India hiring exposure. Experience in pharma, healthcare, or life sciences recruitment preferred. Strong understanding of sourcing strategies, job boards, and networking techniques. Excellent communication and interpersonal skills. Ability to work across time zones and handle multiple requisitions effectively. Proficiency in MS Office and ATS platforms.
Job Title: Engineering Documentation Specialist Sterile Injectable Facility (Remote India) Department: Engineering / Technical Operations Reports To: Associate Director of Engineering / Director of Engineering (U.S.) Location: Remote (India) Supporting U.S.-based pharmaceutical injectable manufacturing facilities Position Overview: The Engineering Documentation Specialist will be responsible for creating, maintaining, and managing all engineering-related documentation for sterile injectable manufacturing facilities operating under FDA 503B or cGMP environments. This position plays a critical role in ensuring technical accuracy, regulatory compliance, and timely documentation of engineering activities, investigations, and quality actions. The ideal candidate will have a solid understanding of pharmaceutical engineering systems, equipment qualification, utilities, and regulatory documentation practices. Key Responsibilities: 1. Documentation & SOP Management Draft, revise, and maintain Standard Operating Procedures (SOPs) related to engineering, maintenance, calibration, and utilities. Ensure all documentation meets FDA, cGMP, and company quality standards. Manage document change requests, track approvals, and ensure controlled document distribution. 2. Engineering Event Documentation Prepare breakdown preliminary investigation reports, work carried out summaries, and detailed root cause analyses (RCA). Utilize 5-Why, Fishbone, and Pareto tools for structured problem-solving and investigation. Coordinate with U.S.-based engineering staff for accurate technical inputs and documentation updates. 3. Deviation & Change Management Draft and document engineering-related deviations, perform investigation summaries, and recommend corrective and preventive actions. Initiate and draft Change Controls, including justification, impact assessment, risk analysis, and implementation documentation. Conduct risk assessments (FMEA/RA templates) and ensure alignment with Quality Management System (QMS) expectations. 4. Project Documentation Support Prepare User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and related technical documents for new equipment, systems, or modifications. Coordinate with vendors and internal stakeholders for technical data collection and documentation consistency. 5. Quality & Compliance Tracking Maintain and update CAPA trackers, ensuring timely follow-up and closure of all engineering-related actions. Track and monitor QMC (Quality Management Committee) action items; ensure all commitments are addressed and closed before deadlines. Support in internal and external audit documentation readiness. 6. Reporting & Presentation Support Prepare and update Engineering MIS (Management Information System) presentations and dashboards for monthly reporting. Prepare QMR (Quality Management Review) engineering sections, including performance metrics, deviation trends, and CAPA status. Support management in compiling data for KPI tracking, continuous improvement, and regulatory compliance metrics. 7. Communication & Coordination Work closely with U.S.-based Engineering, Quality, and Validation teams via email, calls, and virtual meetings. Follow up with cross-functional teams (Maintenance, Validation, Quality, and Projects) to gather inputs for timely document completion. Ensure consistency and traceability between engineering actions and QMS documentation. Qualifications and Experience: Bachelor's Degree in Mechanical, Electrical, Instrumentation, Chemical, or Industrial Engineering (preferred). 38 years of experience in engineering documentation or technical writing within a pharmaceutical / sterile / injectable / 503B environment. Solid understanding of GMP, cGMP, 21 CFR Part 210/211, and 503B guidance. Experience with deviation, CAPA, and change control systems (TrackWise, MasterControl, or similar). Proficient in root cause analysis tools, risk assessment methodologies (FMEA, 5-Why, Fishbone), and compliance documentation. Strong proficiency in MS Office (Word, Excel, PowerPoint, Outlook). Excellent technical writing, analytical, and communication skills. Key Competencies: Strong attention to detail and documentation accuracy. Ability to interpret engineering drawings, maintenance logs, and system reports. Familiar with HVAC, cleanroom systems, purified water, WFI, nitrogen, and compressed air utilities. Proactive follow-up and task closure discipline. Comfortable working independently with remote U.S. engineering leadership. Ability to manage multiple documentation tasks under tight timelines. Preferred Skills: Experience in equipment qualification or validation documentation is a plus. Exposure to audit and compliance documentation for FDA-regulated environments. Experience in MS Power BI or dashboard creation for MIS/QMR reporting. Work Schedule: Flexible remote work hours aligned partially with U.S. time zones (Arizona/PST) for coordination.
Medivant Healthcare is a fast-growing pharmaceutical manufacturing company with a focus on providing high-quality, affordable healthcare solutions. We cater to the U.S. market and are committed to compliance, innovation, and excellence. We are looking for an experienced Sales Team Leader / Supervisor / Manager who has previously worked with U.S.-based companies and understands the nuances of U.S. healthcare sales. Key Responsibilities Lead and supervise the sales team to achieve monthly, quarterly, and annual sales targets. Develop and execute sales strategies focused on the U.S. healthcare market. Manage day-to-day sales operations including pipeline tracking, performance monitoring, and client engagement. Build and maintain strong client relationships with hospitals and healthcare professionals in the U.S. market. Provide coaching, mentoring, and regular performance reviews to sales team members. Collaborate with cross-functional teams (Operations, Supply Chain, Customer Service, and Finance) to ensure seamless customer experience. Monitor market trends, competitor activities, and regulatory changes impacting U.S. pharmaceutical sales. Prepare and present detailed sales reports to senior management. Drive continuous improvement and implement best practices for sales processes and team performance. Qualifications Bachelors degree in Business Administration, Sales, Marketing, or related field (MBA preferred). Over 10 years of experience in Online sales & customer service, including 2-3 years in leadership or supervisory capacity. Demonstrated success working with U.S.-based organizations (preferably within pharmaceuticals, healthcare, or life sciences sector). Strong knowledge of U.S. healthcare sales processes, compliance, and customer expectations. Excellent leadership, communication, and negotiation skills. Ability to analyze data, create sales forecasts, and prepare business presentations. Experience working with CRM tools, reporting software, and MS Office Suite. Goal-oriented, proactive,and able to work in a fast-paced, compliance-driven environment.