Anthea Pharma

Role & responsibilities I. Collaborate with HR Head to understand hiring needs and define job requirements. II. Source and attract candidates through various channels, including job portals, social media, internal databases, headhunting, and networking. III. Conduct initial screening and interviews to assess candidates' qualifications, cultural fit, and interest. IV. Coordinate and schedule interviews with functional heads and leadership teams. V. Manage the entire recruitment life cycle from sourcing to offer negotiation and onboarding. VI. Maintain and update candidate database and provide regular reports on hiring metrics. VII. Build a strong talent pipeline for niche pharma roles and leadership positions. VIII. Stay updated with trends in pharmaceutical hiring and talent availability. Ensure compliance with internal policies and hiring standards Preferred candidate profile Graduate or Postgraduate with a minimum of 4 years of recruitment experience, including at least 23 years specifically in the pharmaceutical or healthcare sector. Proven experience hiring for middle and senior management roles. Strong understanding of pharma functions and organizational structures. Excellent communication, interpersonal, and negotiation skills. Proficiency with ATS, recruitment tools, and MS Office suite. Ability to work in a fast-paced environment and manage multiple roles simultaneously.

Role & responsibilities 1. Operational Procurement Execute purchase orders for approved raw materials, excipients, packaging materials, and engineering items. Coordinate with approved vendors to ensure timely delivery and adherence to specifications. Track purchase requisitions and order confirmations; maintain 95%-100% OTIF, follow up for timely supply against production plans. 2. Vendor Coordination & Documentation Support vendor onboarding by collecting required documents (CoAs, MSDS, BSE/TSE, etc.) and coordinating with QA/RA for qualification. Maintain up-to-date vendor documentation in line with audit and compliance requirements. Support vendor audit preparation and CAPA follow-up, in coordination with QA. 3. Inventory Monitoring & Cost Awareness Monitor inventory levels of assigned categories and alert for potential stock-outs or overstock. Assist in identifying cost-saving opportunities through alternate sourcing or Rate-Contract procurement. Update pricing and procurement data in ERP to ensure accuracy. 4. Cross-Functional Coordination Collaborate with Planning, QA, Production, and Finance teams for procurement-related execution and issue resolution. Support procurement requirements for development batches, trials, or scale-up materials as per In-house and CDMO project timelines. 5. System Handling & Reporting Create and manage POs in Focus ERP and update procurement trackers regularly. Generate daily / weekly procurement MIS reports and escalate supply delays or concerns proactively. Preferred candidate profile 4-7 years of experience in pharma procurement or sourcing. Understanding of APIs, excipients, primary packaging, and process consumables used in injectable pharmaceutical manufacturing. Basic knowledge of GMP and regulatory compliance. Strong communication and follow-up skills. Proficient in ERP systems (Focus/SAP) and MS Excel.

Role & responsibilities To lead and manage the Computer System Validation (CSV) activities for our injectable manufacturing operations. The candidate need to ensure compliance with regulatory requirements (e.g., US FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal quality standards for all GxP-relevant computerized systems used across production, quality control, and laboratory environments. Lead and oversee all CSV activities for GxP-critical systems (LIMS, ERP, MES, SCADA, PLCs, EMS, BMS, etc.) in the injectable manufacturing setup. Develop and maintain validation master plans (VMPs), risk assessments, validation protocols (IQ/OQ/PQ), and reports in line with regulatory expectations and industry best practices. Ensure validation lifecycle management, including periodic review, re-validation, and change control assessments. Collaborate with IT, Quality, Engineering, Production, and external vendors to ensure smooth implementation and validation of new computerized systems or upgrades. Drive data integrity initiatives and compliance across computerized systems and related workflows. Conduct internal audits, gap assessments, and readiness checks for regulatory inspections related to CSV. Provide training and guidance to cross-functional teams on CSV policies, procedures, and regulatory updates. Track regulatory developments and industry trends to continuously improve CSV and data integrity frameworks Preferred candidate profile B.E./B.Tech or a Masters in Pharmacy with 12 - 16 years of experience in Computer System Validation within regulated pharmaceutical manufacturing, preferably injectable / sterile dosage forms. Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity guidelines. Hands-on experience with LIMS, ERP, SCADA, BMS/EMS, and electronic batch records. Experience in handling regulatory inspections (e.g., USFDA, MHRA, EU, WHO) from a CSV perspective

Role & responsibilities Validation & Qualification Oversight Prepare and maintain Validation Master Plans (VMP) in alignment with corporate and regulatory guidelines. Review and approve qualification documentation including URS, DQ, IQ, OQ, PQ, RQ , ensuring completeness and compliance. Supervise execution activities and guide the team during validation and qualification stages. Oversee and review Performance Qualification (PQ) , Requalification , interim and summary reports , and addenda . Documentation & SOP Management Develop and review validation protocols , SOPs, and QA documentation related to equipment, facility, and utility qualification. Review and ensure compliance of SOPs from other departments that impact validation and qualification processes. Ensure proper documentation control, including version management and approval routing. Project Management & Execution Ensure timely completion of validation activities in alignment with project milestones and regulatory timelines. Review layouts and engineering drawings for facilities, utilities, and equipment to ensure compliance and suitability for intended use. Maintain and oversee revalidation schedules in accordance with change control and periodic review programs. Deviation & Change Control Handling Investigate and document validation-related deviations and change controls , recommending and implementing appropriate corrective and preventive actions (CAPAs) . Collaborate with cross-functional teams to resolve validation and qualification issues proactively. Training & Team Development Mentor and train QA validation team members on current practices, regulatory expectations, and internal standards. Conduct knowledge-sharing sessions to build team capability in equipment, facility, and utility validation . Compliance & Continuous Improvement Ensure cGMP compliance in all validation and qualification activities, maintaining a validated state at all times. Continuously evaluate and improve validation systems, practices, and documentation to meet evolving regulatory requirements. Preferred candidate profile Bachelors or Master’s degree in Pharmacy with 8–12 years of relevant experience in QA Validation within a regulated injectable manufacturing facility . Proven expertise in equipment / facility / utility qualification , process validation , and cleaning validation . Strong knowledge of regulatory guidelines : cGMP, 21 CFR Part 11, EU Annex 1, WHO TRS, ICH Q8-Q10. Experience in deviation handling , change control , and validation risk assessments . Ability to read and interpret engineering drawings , layouts, and P&IDs. Hands-on experience with documentation systems and quality management systems (QMS).

Role & responsibilities To lead and manage utility systems in a sterile injectable manufacturing facility. The candidate should have strong experience in pharmaceutical utility operations, maintenance, and regulatory compliance Oversee the operation and maintenance of all utility systems HVAC, compressed air, purified water, WFI, clean steam, chillers, boilers, etc. Ensure 24x7 availability of utilities for uninterrupted manufacturing. Plan and implement preventive and breakdown maintenance schedules . Ensure all utility operations comply with cGMP, USFDA, and other regulatory standards . Lead utility qualifications (IQ/OQ/PQ) and support audits and inspections. Coordinate with engineering, production, and QA/QC for smooth plant operations. Manage energy efficiency, safety, and sustainability initiatives. Guide and train the utility team for skill development and compliance Preferred candidate profile Bachelors / Masters degree in Mechanical/Electrical Engineering, or related field. 12–20 years of experience in utility operations within pharmaceutical (injectable/sterile) manufacturing. In-depth knowledge of pharma utility systems and regulatory requirements Experience with GMP documentation , equipment qualification, and audit handling Familiar with regulatory standards (USFDA, EU GMP, etc.) Good communication and documentation skills Perks and benefits

Role & responsibilities JOB RESPONSIBILITIES 1. Responsible to establish overall Production plan for the site. 2. Responsible for coordination with Cross function team in securing the inputs required for mapping the schedule. 3. Responsible to ensure to materials availability well before execution of the batches on line. 4. Coordination with respective stake holders in getting the inputs on the material releases. 5. Responsible to prepare production plan weekly/fortnightly/monthly plans. 6. Intimation/ submission of production plans to all cross functional teams. 7. Responsible to keep the relevant team informed on the plan changes. 8. Responsible to accommodate the priority products/adjustment of plans 9. Monitoring of production plans and their actual basis for plan adjustments. 10. Coordination with manufacturing/QA on the process orders & batch document issuance prior to batch execution inline with production plan. 11. Coordination with Quality Control on the material releases/re prioritization of material releases based on the production plan. 12. Responsible to maintain Master data for all products to support production plan. 13. Coordination with Alliance management in securing confirmed Purchase orders/ sales orders to accommodate process orders to support batch execution. 14. Coordination with warehouse in ensuring the material issuance for the planned products. 15. Responsible to initiate change controls as per the QMS related to production plan. 16. Responsible to establish material shortages for the products and follow-up with procurement in getting their delivery schedule for plan adjustments. 17. Coordination with R&D in mapping Scaleup execution batch plan for the priority products. 18. Responsible to arrange dispatch plan for the monthly to ensure on time shipments. 19. Coordination with Warehouse and Quality control departments in getting the non moving materials / retest materials to liquidation plan & testing of materials prior to Retest date to avoid write offs. Preferred candidate profile 10-15 yrs experience in PPIC(injectables) Qualification: M. Pharmacy / B. pharmacy / M.Sc

Required Skills Strong understanding of global patent laws (US, EU, India, etc.). Experience with patent prosecution, litigation support, and FTO analysis. Ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate across teams. High integrity, professionalism, and ethical conduct. Overview This position is responsible for managing all aspects of Intellectual Property Rights (IPR) within the pharmaceutical business. The role includes developing and implementing IP strategies, patent portfolio management, conducting freedom-to-operate (FTO) analyses, and supporting R&D and business development with IP-related inputs. The position plays a key role in safeguarding the company's innovations and maximizing the commercial value of its IP assets. Key Responsibilities: I. Lead patent strategy development to support R&D and commercial objectives, ensuring alignment with global IP laws and business goals. II. Oversee patent drafting, filing, prosecution, and lifecycle management for new chemical entities, formulations, processes, and other innovations. III. Conduct detailed patent landscape and freedom-to-operate (FTO) analyses to guide product development and market entry plans. IV. Collaborate with R&D and formulation teams to identify inventions and manage invention disclosure processes. V. Manage oppositions, revocations, and patent litigations in coordination with external legal counsel and internal stakeholders. VI. Monitor competitor IP filings and proactively develop strategies for challenging or circumventing third-party patents. VII. Support business development activities through IP due diligence, contract reviews, and licensing assessments. VIII. Ensure global IP compliance and manage relationships with patent attorneys and regulatory experts across multiple markets. IX. Develop and deliver training programs to increase IP awareness among scientific and commercial teams. X. Contribute to regulatory strategy by advising on exclusivity periods, patent linkage issues, and IP-related regulatory pathways (e.g., Paragraph IV filings, data exclusivity).

Role Overview The Finance Internal Auditor will be responsible for conducting risk-based financial, operational, and compliance audits across the pharmaceutical business. The role ensures that internal controls are effective, financial records are accurate, and business operations comply with industry regulations (SOX, GMP-related financial controls, etc.). The position plays a key part in strengthening governance, improving processes, and ensuring audit readiness. Key Responsibilities Perform financial and operational audits covering accounting, procurement, treasury, payables/receivables, and inventory management. Evaluate adequacy and effectiveness of internal controls in compliance with company policies, pharma regulations, and international standards (COSO, SOX, IIA guidelines). Conduct audits of manufacturing plants, R&D units, distribution, and corporate offices focusing on financial processes and cost controls. Review revenue recognition, costing, and transfer pricing in line with accounting standards and pharma-specific rules. Assess controls around SAP/ERP systems , including user access, segregation of duties, and data integrity. Identify control gaps and recommend process improvements and cost efficiencies . Prepare clear and concise audit reports with findings, risk impact, and corrective action plans. Follow up with business units to ensure implementation of corrective/preventive actions (CAPA) . Support management in risk assessments, fraud investigations, and regulatory inspections . Qualifications & Skills Education BCOM / MBA (Finance), CA Inter Experience 4-5 years of experience in internal audit, finance, or risk management , preferably in a pharma, biotech, or manufacturing industry . Hands-on experience with SAP/Oracle ERP and exposure to SOX/IFC controls . Skills & Competencies Knowledge of accounting standards (IFRS/Ind-AS/US GAAP) . Understanding of pharma industry financial processes (inventory costing, R&D capitalization, sample accounting, tender pricing, etc.). Analytical, investigative, and problem-solving skills. Excellent communication, report writing, and stakeholder management. High integrity, independence, and ability to handle sensitive information. Key Performance Indicators (KPIs) Timely completion of audit plans. Quality of audit findings and recommendations. Implementation rate of corrective actions. Contribution to cost savings or process improvements. Compliance with regulatory and company audit standards.

Role & responsibilities We are hiring experienced Groninger Machine Operators and Production Executives with a strong background in managing Vial Filling and PFS (Pre-Filled Syringes) Lines. The ideal candidates should have hands-on experience with Groninger machinery, ensuring smooth production operations while maintaining strict quality and safety standards. Key Responsibilities: Operate, monitor, and maintain Groninger machines used in Vial Filling and PFS Lines. Ensure seamless production flow, achieving targets without compromising on quality. Perform routine maintenance and troubleshooting of machines to prevent downtime. Monitor process parameters and ensure compliance with GMP (Good Manufacturing Practices). Conduct in-process checks and ensure adherence to standard operating procedures (SOPs). Collaborate with quality control and assurance teams to ensure product integrity. Maintain detailed records of production activities, machine performance, and quality checks. Implement safety protocols and contribute to a safe working environment. Preferred candidate profile Educational Qualification: Diploma / Engineering Degree in Mechanical / Pharmaceutical. Experience: Minimum 2-6 years of hands-on experience in operating Groninger machines, specifically in Vial Filling and PFS Lines. Strong knowledge of GMP, regulatory guidelines (USFDA, / MHRA / EU), and production documentation. Ability to work in a team-oriented environment with minimal supervision. Experience with other filling machines in sterile environments. Knowledge of automation and control systems. Familiarity with machine calibration and validation processes. Perks and benefits

Overview We are seeking a strategic and results-oriented Business Development Manager to drive the expansion of Anthea's footprint in the US Regulatory market. This key leadership role will focus on establishing and nurturing relationships with potential partners and stakeholders while driving business growth across B2B Out-Licensing, Contract Manufacturing Opportunities (CMO), and Contract Development & Manufacturing Opportunities (CDMO) within the US region. The ideal candidate will possess a deep understanding of the regulatory landscape, excellent relationship-building skills, and the ability to generate and execute growth strategies. Role & responsibilities Develop and implement strategies to expand Antheas presence in the US Regulatory market, focusing on B2B Out-Licensing, CMO, and CDMO services. Build and maintain long-term relationships with potential clients, partners, distributors, and key stakeholders across the US. Lead negotiations and close deals related to contract manufacturing, development services, and out-licensing agreements. Collaborate with senior management to develop and execute tailored business strategies for the US market, leveraging industry trends and market insights. Represent Anthea at industry trade shows, exhibitions, and conferences across the US to promote the companys services and generate new business leads. Conduct market research to analyze industry trends, competitor activities, and customer needs in the US region, providing actionable insights to inform business strategies. Travel regularly to the US for client meetings, business development activities, and networking opportunities. Work closely with internal teams, including R&D, Operations, and Legal, to align business development efforts with the companys broader goals and ensure successful outcomes. Preferred candidate profile In-depth knowledge of the US regulatory pharmaceutical market, including key players, trends, and regulatory processes. Strong negotiation, communication, and interpersonal skills, with the ability to engage and collaborate with stakeholders across various cultural and market contexts. Excellent verbal and written communication skills, with an ability to articulate complex concepts clearly and persuasively. Proven track record of success in driving business growth, developing strategic partnerships, and securing high-value contracts. Strong analytical and market research skills to assess industry trends, competition, and opportunities. Experience 10+ years in business development within the pharmaceutical sector, with a strong focus on finished dosage forms, preferably injectables. Experience with B2B out-licensing, CMO, and CDMO services is highly desirable.

Role & responsibilities Risk based life cycle approach to validate GxP Computerized System as per GAMP5. Hand on experience on validation of Enterprises application like LIMS, ERP, eBR ; Manufacturing system like HMI/SCADA and Laboratory system like Empower, Lab solution, Tiamo etc Preparation and review validation deliverable like GxP Assessment, Vendor Assessment URS, Risk Assessment, IQ/OQ/PQ (Protocol ,script and Report), RTM, ER-ES Assessment and VSR. Can independently execute the OQ script and support during IQ and PQ execution. Extensive knowledge on 21 CFR Part 11 and EU Annexure 11. Preparation, Review, execution and compilation of process equipments, HVAC and utilities protocols and reports. Preparation, Review, execution and compilation of all the qualification protocols of laboratory and manufacturing systems Initiate request for protocols and annexures. Participate in FAT and SAT of process equipment's and utilities and review of vendor documents. Preparation of Qualification certificates and handover the same to Documentation cell. Review of all Protocols, Reports and Documents with relevant to CGMP. To update validation master plan. Update and Review of Logbooks. To ensure CGMP compliance in all related activities. Preparation, Review, execution, compilation and report preparation of General study protocols. Tracking of all documents. Ensure all laboratory & manufacturing activities are performed as per CGMP/GLP. Preparation and Review of Periodic Review Schedule. Execution and Review of Equipment and Systems Periodic Review as per Periodic Review Schedule. Preparation and Review of Requalification Schedule. Execution and Review of Equipment Requalification as per Periodic Requalification Schedule. Preferred candidate profile 3-5 yrs Exp. in CSV(QA) Exp. in laboratory, Manufacturing Equipment's, Utility systems.