*Market Research & Opportunity Identification: Conduct market research to identify new business opportunities and emerging trends in the API sector, targeting both domestic and international markets. *Business Development & Client Acquisition: Actively seek and acquire new clients, including pharmaceutical manufacturers and distributors, to expand the customer base for API products. *Sales Strategy & Execution: Develop and implement strategies to achieve revenue targets, negotiate contracts, and deliver tailored proposals to clients in the API sector. *Partnerships & Collaborations: Build and maintain strategic partnerships with stakeholders, including regulatory bodies and pharmaceutical companies, to drive API product growth. *Customer Relationship Management: Serve as the main point of contact for clients, addressing inquiries and ensuring high levels of customer satisfaction and long-term loyalty. *Market Intelligence & Competitor Analysis: Stay informed on industry trends, competitor activities, and regulatory changes, providing valuable insights to senior management. *Cross-Functional Collaboration: Collaborate with internal teams like R&D, manufacturing, and regulatory affairs to ensure timely product delivery and customer satisfaction. *Reporting & Forecasting: Prepare regular reports on business development activities, track sales progress, and provide accurate sales forecasts to management. *Industry Networking: Represent the company at conferences and trade shows to generate new leads and network with key industry influencers and potential clients.

*Operational Leadership: Lead and manage the day-to-day operations of BJHL, ensuring efficiency and effectiveness across all departments. *Develop and implement operational strategies that align with the company’s goals and objectives. *Process Optimization: Identify and implement process improvements to enhance operational efficiency, reduce costs, and improve product quality. *Utilize Lean, Six Sigma, or other methodologies to drive continuous improvement initiatives. *Supply Chain Management: Oversee the entire supply chain, ensuring timely and cost-effective procurement, production, and distribution of products. *Build and maintain strong relationships with suppliers and logistics partners. *Quality Assurance: Ensure compliance with all regulatory requirements and industry standards. *Implement and maintain robust quality management systems to ensure the highest product standards. *Financial Management: Develop and manage the operations budget, ensuring cost control and financial performance. *Analyze financial data to identify areas for improvement and ensure profitable operations. *Team Leadership: Build, lead, and mentor a high-performing operations team. *Foster a culture of collaboration, accountability, and continuous learning. *Strategic Planning: Collaborate with senior leadership to develop and execute the company’s strategic plan. *Identify new opportunities for growth and expansion, including new product lines and markets. *Project Management: Oversee and manage large-scale projects, ensuring they are completed on time, within scope, and within budget. *Coordinate cross-functional teams to achieve project goals. *Customer Focus: Ensure operational excellence to meet and exceed customer expectations. *Work closely with the sales and marketing teams to align operations with customer needs and market demands. *Innovation and Technology: Drive the adoption of new technologies and innovative solutions to improve operational performance. *Stay abreast of industry trends and advancements to keep BJHL at the forefront of the pharmaceutical industry.

*Responsible for sourcing of API, KSM & all critical products for R&D projects & commercials in Regulated & Un-regulated Market. *To support projects and to realize year-on-year productivity improvements, cost savings, and process improvements *Planning, organizing, and managing projects taking into account priorities.

• Accountable & responsible for business development activities carried out according to corporate strategy • Responsible for overall revenue growth - Planning and achievement of annual target volumes, new market strategy, process validation & regulatory filing & customer management • Involved in product registration related to regulatory compliance and documentation • Responsible for coordination with internal, external & regulatory stakeholders • Grow business in area of influence by selecting and developing approved new Suppliers and wholesalers • Broadening the product range/volume in the existing customer base • Explore tender/rate contract opportunities in potential institutions and ensure timely communication to sales manager • Identify new partners in the existing territories • Discover new territories & partners • Support in identifying new potential products in existing as well as new territories

Handling of HPLC Handling of GC Handling of UV.Vis Spectrophotometer

Required Skills: • Resource with 2 -8 years of Relevant experience in Computerized System Validations of Enterprise applications (SAP/LIMS/TrackWise etc.), Equipment and Instrument validations (Manufacturing, Packaging, QC equipment/instruments and Serialization etc.). • Experience in Preparation and Execution of CSV deliverables (IQ, OQ and PQ). • Exposure in Assessment, Review and Preparation of 21 CFR part 11, EU annex 11 Compliance Assessment/Report. • Review of User, Error, Audit Trail records. • Skilled in Risk Assessment for Equipment/Instrument Operations. • Experience in Handling of QMS events (Change control, Deviation, RCI and CAPA). • Experience in Handling of end to end project CSV activities (is an added advantage). Technical Skills required: • Knowledge on handling of ValGenesis Application. • Hands on instrumentation, semi automation or automation • Worked on different layers of automation systems • Knowledge of IT- Operations, data and security management, backup & restore activities, • Exposure to maintenance, troubleshooting of GxP systems, • Understanding of technical & procedural risk assessment and actions. Soft skills (behavioral) required: Self-learner, Team player, Good Communication and Coordination with CFT etc. Any other specification / Requirement: • B. Tech, B.E. B.Sc. – Instrumentation /Electronics/ IT /B. Sc. (Computer Science) having knowledge of SAP, TrackWise, MES, BMS, EMS etc. • B. Pharmacy with exposure in regulation, analytical instrumentation, exposure to production activities along with exposure to latest software LIMS, HPLC etc. Experience Range: 2 to 8 years in Engineering, Consultancy, IT, CSV in Pharma domain

Job Summary: We are seeking an experienced Labware LIMS Developer with 3 to 7 years of hands-on experience to join our team. The ideal candidate will possess a deep understanding of Labware LIMS software and its integration into laboratory processes. The candidate will be responsible for the design, development, customization, and support of the LIMS system.Key Responsibilities: Labware LIMS System Development and Customization: Design, develop, and implement Labware LIMS configurations, enhancements, and customizations. Develop and maintain Labware LIMS workflows, interfaces, and modules. Create custom reports, dashboards, and data visualizations within the Labware LIMS platform. Integrate Labware LIMS with other laboratory systems and enterprise systems (e.g., ERP, CDS and Empower). System Support and Maintenance: Provide ongoing support for Labware LIMS by troubleshooting issues, identifying bugs, and implementing solutions. Perform system upgrades and patch management for Labware LIMS. Monitor system performance, address issues, and ensure data integrity and reliability. Collaboration and Requirement Gathering: Work closely with laboratory and business teams to understand system requirements and ensure LIMS meets operational needs. Prepare and maintain technical documentation, including requirements, system configurations, and testing procedures.Required Qualifications: Experience: 3 to 7 years of hands-on experience in Labware LIMS development, customization, and support. Technical Skills: Strong experience with Labware LIMS software, including configuration, customization, and implementation. Proficiency in programming languages such as JavaScript, C#, or Java, and experience with Labware LIMS scripting. Experience with SQL and database management (e.g., MS SQL Server, Oracle). Familiarity with Labware LIMS integration technologies (e.g., web services, APIs, XML). Experience with LIMS testing, validation, and documentation for regulatory compliance. Education: Bachelor’s degree in Computer Science, Information Technology, or related field (or equivalent experience). Knowledge of Regulatory Standards: Understanding of regulatory guidelines such as 21 CFR Part 11, GxP, and other industry-specific standards. Problem-Solving Skills: Strong analytical skills with the ability to troubleshoot and resolve technical issues effectively. Communication Skills: Excellent verbal and written communication skills, with the ability to collaborate effectively with both technical and non-technical teams. Team Player: Ability to work effectively within a team and independently in a fast-paced environment.

*Responsible for configuring, testing, and migrating MES recipes to ensure smooth operations in the manufacturing environment. This role involves troubleshooting issues related to shopfloor execution and working closely with cross-functional teams to support MES system integration. The candidate will also prepare functional and user requirement specifications, perform bug fixes, and review qualification documents. *MES Recipes Configuration, Testing, Qualification, Migration *System Bug Fixing and Troubleshooting of Shopfloor Execution Errors *Functional Specification Preparation *URS (User Requirement Specification) Preparation for Applications *Review and Approval of Qualification Documents *Integration of L2 MES Systems and Recipe Development *Provide Execution Support and Ensure Smooth MES Operations

• Responsible for Regulatory filings for APIs and Intermediates and achieving registrations-DMF (US, Europe, Australia, Korea, Japan, WHO, other reg / non reg countries), CEPs. • Responsible for coordination of all Regulatory Query responses with agencies, regulatory related query responses with customers. • Ensure that all regulatory requirements for successful registration are addressed during development and validation – Specifications, Impurity profiles, Different regulatory requirements wrt impurities, starting materials, analytical and process validations. • Life cycle management of DMFs, Registrations -Annual reports, change updations • Support during regulatory audits. • Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc • Review of supplier documentation for regulatory requirements

Arcolab is looking for RPA lead. Pls find the JD as below.Key Responsibilities of RoleModelling and architecting robotic processes during the project development stageGovern RPA processes from development to deployment. Follow Quality Assurance (QA) & Compliance processes to ensure quality AutomationsUpdating and maintaining Developer Standards around RPA best practicesTechnical Skills :Minimum 5 years of experience in a UI-path ecosystem.Experience in developing workflow-based solutions or functionalityShould Lead team of 5+ members on Development, Operations & Support.Must be able to multitask and willing to work on multiple projects at a given timeStrong written and verbal communication skillsAbility to work on deadlines and manage expectationsStrong analytical and problem-solving skills

Operation and Maintenance, of such equipment’s as Refrigeration unit, Air Compressor, PSA Nitrogen Generation System, Steam Boiler, cooling towers, Softener, Purifier water plant etc. Monitoring of Utilities efficiency as Water chillers, Brine units, Air compressors, Nitrogen Generation System, Steam Boilers, and Cooling Towers. O & M of Purified Water plant including sanitization, Pretreatment regeneration, validations etc. Responsible for the Clean Room area Maintenance as differential Pressure Balancing and environment conditions within the limits. Co-ordination with suppliers for Material and services as required, planning for the existing plant team, as well as our service team also. Plant modification, shifting erection of equipment’s & prepare their related documents for qualifications & validations. Handing periodic validation of HVAC system /clean area & preparing protocol, arrangement of outside agency to perform activity Maintaining engineering related documents as equipment Qualifications’ change controls, Project, Documents, Preventive maintenance documents & others. Responsible for implementing new technologies, cost and resource saving techniques and new innovation to improve efficacy in various routine and non routine activities at site Responsible for Temperature Mapping & validation of specific area’s activities. Responsible for implementing current good engineering practices (cGMP). To support with all statutory requirements like Boiler Inspection and others as applicable.

• To lead the Manufacturing Process within the company and Responsible for Profit & Loss of Plant. • Will be responsible for planning the production and operations activities simultaneously enabling the procurement /SCM for seamless business requirement. • To be responsible for all WHO audits, factory Licenses, statutory compliances applicable at plant level. • Streamline the operations in the most cost optimized manner at the maximum resource utilization and Manpower planning to optimize the cost of production.

• Responsible for planning, execution & commissioning of new projects within specific time frame. • Planning & execution various projects at plant level in regards with new facility development, Energy Management & other facility up gradations in regards with GMP & Safety. • Co-ordination with suppliers for Material and services as required for implementation of projects. • Responsible for preparing monthly and yearly budget for projects. • Responsible for implementing good engineering practices during project . • Responsible for implementing new technologies, cost and resource saving techniques and new innovation during projects for improvement and cost saving

• Ensure compliance with Stage Gate and Design QA procedures. • Coordination between different stake holders – R&D, QC, QA, RA, Project Management for effective Stage Gate reviews and clearances of Stages. • Review PDRs, Scale up reports including Lab Note books • Participate in designing DOE trials in line with Process • Review Scale up protocols, Exhibit protocols, Process Validation protocols and reports • R&D IPQA • R&D procedural compliances – Qualifications, Calibrations, RLD Management, Stability Management • Responsible for deviation, investigation related to R&D. • Responsible for specification/STP review. Review and clearance of Analytical Method Validations • R&D Documentation Management -Issuance and retrieval • Responsible for clearing Formulation Projects for Scale up and Exhibit batches.

• Responsible for QA activities & review of documents in the area of: • Quality Management Systems, Incidents & Investigations, IPQA, Internal Audits • Document control • Batch review and release, Dispatch • Validations, Qualifications • Product Quality review • Logging, Investigating and closing Quality events (Deviations, OOS&OOTs, Complaints), Participate in Investigations • Logging, Tracking, Closing Changes, CAPAs • IPQA and Internal Audits • Document Management – Issuance, Retrieval, Archival • Review of Quality System documents such as -Batch records, Validation reports, Qualification reports, calibration reports • Review Dispatches and documentation • Review Vendor Qualification, • Coordinate Training Management, Samples dispatch • Sampling of intermediate/ APIs

• Responsible for Defining and Implementation of Quality Management system and Quality Assurance processes across OSD and CMO/ CRO locations. • Ensuring compliance with all cGMP requirements in line with global and Indian regulatory requirements • Handling all Regulatory audits, Client Audits, Internal Audits • Responsible for Qualification /Audit of CxP Vendors and CxP service providers • Responsible for GxP Training • Responsible for providing all documentation and other necesary support for Regulatory for product registrations and life cycle management • Responsible for providing all documentation and other necessary support for Business / Marketing, Customers • Responsible for management of Deviations, OOS, Complaints, Changes, Qualifications, Validations • Responsible for Licenses, Certifications and compliance (Indian FDA / CDSCO)

• Responsible for analytical documents review, filing after approval for: • Batch Analysis • Method Validation and Method Transfers • OOS / OOT Investigations • Stability Protocols, Reports, Data • Certification of standards • Review of Specifications and Test Methods • Review of Calibration and Qualifications of Analytical Instruments • Audit trail review • Should understand all analytical instruments like HPLC, GC, Spectrophotometers, Other analytical instruments • Understanding of good laboratory practices in Quality control and Analytical Development and Validation • Understand 21CFR Part 11 requirements, Audit trail reviews, GMP requirements, ICH guidelines on Specifications, Method validations.

• Responsible for Operations of Quality control • Implementation of all Quality control procedures, Maintaining and Upgrading systems and processs in Quality control to meet most stringent regulatory requirements (GMP / GLP) • Handling all Regulatory audits, Client Audits, Internal Audits in QC • Planning and coordination for analysis and release of Input, Inprocess, Final products in time • Planning and management of resources for Quality control – Instruments, Chemicals and consumables, Manpower. • Providing all documentation and other necessary support for Regulatory for product registrations and life cycle management from Quality control

• To ensure that All Operational Equipment’s should be available on time for production. • Reduce the Equipment down time to minimum 3percent. • To ensure that all activities are in a safe manner and adhere to the norms. • To ensure that all Electrical, civil and instrumental activities should be done in time. • Take care of all Utility equipment’s like chilling plants, cooling towers, VAM, Boiler, Water system, HVAC, Vacuum system, Thermic fluid system and its circulation pumps • To maintain the equipment inventory management system. • Control the monthly budget to meet committed KRA. • To develop the second level team and maintain good co-ordination among all depts. • Prepare the qualification, SOP and Change control documents to meet CGMP norms and Good Knowledge in GMP Requirements • Address the building maintenance system. • To Initiate Energy conservation activities and implement the same with proper approval. • Manpower Attrition control mechanism with motivate skills and training methods. • Prepare daily report and forward the same to site head and corporate Engineering team. • Prepare monthly reports and circulate the same to concerned teams. • Review the key result areas as committed in financial year to the top management.

• Must have experience in analytical method development of peptide molecules. • Experience in method development of peptide molecules and Fmoc-Amino acids by HPLC and UPLC techniques. • Experience in handling of various peptide related analytical methods like AAA(Amino acid analysis), SEC(Size exclusive chromatography), Peptide Assay, Oligomers content. • Knowledge in characterization data of peptides i.e. Amino acid sequencing by LC-MS/MS by Q-Tof, HRMS and NMR. • Experience in handling of routine analysis of peptides by HPLC, GC, ICPMS and wet analysis.

*Process Management: Expertise in overseeing production processes, ensuring efficiency, compliance, and quality standards. *Production Planning & Scheduling: Ability to develop production plans that align with customer demand and business goals, optimizing resource utilization. *Leadership & Team Management: Proven track record in leading cross-functional teams, fostering collaboration, and driving high-performance cultures. *Regulatory Knowledge: Deep understanding of industry standards (GMP, FDA, EMA, ICH) and the ability to ensure compliance across all levels of production. *Quality Assurance: Strong focus on maintaining product quality, managing deviations, and implementing corrective and preventive actions (CAPA). Problem-Solving & Troubleshooting: Skilled at identifying issues in the manufacturing process, analyzing root causes, and implementing solutions quickly. *Process Optimization: Familiarity with Lean Manufacturing, Six Sigma, and other methodologies to improve operational efficiency and reduce costs. Equipment Maintenance & Management: Proficient in overseeing the upkeep, calibration, and validation of manufacturing equipment. *Safety & Compliance: In-depth knowledge of occupational health and safety standards, ensuring safe working environments.

• Educational and Certification Requirements: Degree in Environmental Science, Engineering, or Sustainability, with relevant certifications (ISO, ESG frameworks). • Industry Expertise: EHS roles within the pharmaceutical sector, with knowledge of ZLD operations and hazardous waste management. • ESG Reporting: Experience with GRI, BRSR, SASB, and CDP reporting, and sustainability disclosure for stakeholders. • Sustainability Implementation: Proficiency in carbon and water management, green chemistry, resource optimization, and waste reduction. • Leadership and Communication: Ability to lead cross-functional initiatives and engage with stakeholders and local communities.

Arcolab Pvt Ltd is looking for a Data Scientist, Pls find the JD below. 1.Modelling and developing Machine Learning solutions 2.Carrying out pre-processing, cleansing of structured and unstructured data for ML models 3.Implement solutions for prediction systems and machine learning challenges 4. Monitor and Maintain ML/AI builds post implementation 5. Follow Quality Assurance (QA) Compliance processes to ensure quality 6. Automations 7. Updating and maintaining Standards around Industry best practicesTechnical Skills Required:1. Minimum 3 years of experience in a Data Scientist role 2. Experience in developing ML based solutions or functionality 3. Experience in Cloud technologies 4. Must be able to multitask and willing to work on multiple projects at a given time 5. Strong written and verbal communication skills 6. Ability to work to deadlines and manage expectations 7. Strong analytical and problem-solving skills

Intercompany Open GRN & Reconciliation:1.Interaction with the concerned team for the Invoices to account and clear GRN for intercompany transactions.2. Follow up to account & clear Open GRN & raise DN/CN for any price diff3 Follow up to account intercompany DN/CN/Support service/Cross charge to match intercompany4 Follow up with GRN team to reverse Duplicate GRN & discuss with BU, if any5. All Intercompany Reconciliation & Sending emails to respective Intercompany team to update the same in their books6. Obtain Balance Confirmation on all entities wherever we have requirement on audit perspective.7 Closure entries to update like TP adjustment entries and follow up to update with intercompany Audit : 1) Quarterly Audit (KPMG- In India),2) Bank Audit US (In US),3)Tax Audit PWC (In India Tax Team) – Co-ordinate with Tax team.Controllership :1Controller needs to complete all audits on time2. Follow up with team to get audit requirement/supporting's to auditor on time & review thesame before sharing3. Preparation & share Provisions movement schedule4 Preparation & share RPT movement schedule5. GRIR follow up for closures6. Oversee Vendor reconciliationMonthly Closure:1. Execution of Forex Exchange Restatement (Intercompany GL's)2. Review & Discuss with BU for the variances of major Opex cost3. GL Review and update the reasons for Variances month on month4. Prepare & Share to Consol/BF team Profit & Loss Account Monthly variance report &update reasons for variance of Opex cost -Quartely5. Prepare & Share Provisions schedule to share consol/BF team6. Follow up with FA & CWIP team for the Schedule and interaction with US team for any clarifications7. Provide required details or Schedules to Consol team/BF team as & when required.8. Posting of all parked entries into SAP9. Interaction with US team regularl8.y10 . Bank Reconciliation Statement on a weekly basis and month end to share with BUs.11. Interaction with US team/Costing Team/BF team to implement the process wherever necessary

Qualification: MBBS Experience: 1 to 3 years Previous experience in medical review of ICSRs.Knowledge of safety databases, such as Argus, ARISg, or similar systems.Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B).Strong attention to detail and ability to work with complex medical data.Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.Key Responsibilities:Individual Case Safety Reports (ICSRs) Review:Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature.Assess the medical relevance and causality of adverse events reported in ICSRs.Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary.Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.

Labware LIMS Developer roleJob Summary: We are seeking an experienced Labware LIMS Developer with 3 to 7 years of hands-on experience to join our team. The ideal candidate will possess a deep understanding of Labware LIMS software and its integration into laboratory processes. The candidate will be responsible for the design, development, customization, and support of the LIMS system.Key Responsibilities:Labware LIMS System Development and Customization:Design, develop, and implement Labware LIMS configurations, enhancements, and customizations.Develop and maintain Labware LIMS workflows, interfaces, and modules.Create custom reports, dashboards, and data visualizations within the Labware LIMS platform.Integrate Labware LIMS with other laboratory systems and enterprise systems (e.g., ERP, CDS and Empower).System Support and Maintenance:Provide ongoing support for Labware LIMS by troubleshooting issues, identifying bugs, and implementing solutions.Perform system upgrades and patch management for Labware LIMS.Monitor system performance, address issues, and ensure data integrity and reliability.Collaboration and Requirement Gathering:Work closely with laboratory and business teams to understand system requirements and ensure LIMS meets operational needs.Prepare and maintain technical documentation, including requirements, system configurations, and testing procedures.Required Qualifications:Experience: 3 to 7 years of hands-on experience in Labware LIMS development, customization, and support.Technical Skills:Strong experience with Labware LIMS software, including configuration, customization, and implementation.Proficiency in programming languages such as JavaScript, C#, or Java, and experience with Labware LIMS scripting.Experience with SQL and database management (e.g., MS SQL Server, Oracle).Familiarity with Labware LIMS integration technologies (e.g., web services, APIs, XML).Experience with LIMS testing, validation, and documentation for regulatory compliance.Education: Bachelors degree in computer science, Information Technology, or related field (or equivalent experience).Knowledge of Regulatory Standards:Understanding of regulatory guidelines such as 21 CFR Part 11, GxP, and other industry-specific standards.Problem-Solving Skills: Strong analytical skills with the ability to troubleshoot and resolve technical issues effectively.Communication Skills: Excellent verbal and written communication skills, with the ability to collaborate effectively with both technical and non-technical teams.Team Player: Ability to work effectively within a team and independently in a fast-paced environment.

Registration / Submission of Drug Master Files (DMFs) for APIs with different agencies such as USFDA, EDQM/CEP, EDMF with European Authorities, WHO (including Prequalification), Korea, Brazil, Australia, LATAM, Other Emerging markets Responsible to compilation of DMFs, Review of DMFs and ensure that the DMFs complies with the ICH / USFDA / WHO / European and other applicable regulatory guidelines Responsible for receiving and responding to regulatory queries with respect to DMFs Life cycle management of DMFs -Annual Reports, Change Updates Track updates to Regulatory guidelines, Pharmacopeias and other applicable documents and guidelines and inform management and the team regularly. Responsible for handling queries regarding registration, DMFs during site audits. Responsible to review all product related documentation that goes into the DMF and / or supports the DMFs

Responsible for coordinating investigation of deviations, out of specifications, complaints, technical report writing on investigations, track CAPA implementation Responsible for logging and coordinating investigation of IPQA observations, deviations, OOS, OOTs, Complaints Compilation of investigation details and Technical Report writing for failure investigations. Logging CAPAs and Tracking implementation of CAPA Presenting and explaining failure investigations to regulatory auditors, customer auditors

Registration / Submission of Drug Master Files (DMFs) for APIs with different agencies such as USFDA, EDQM/CEP, EDMF with European Authorities, WHO (including Prequalification), Korea, Brazil, Australia, LATAM, Other Emerging markets Responsible to compilation of DMFs, Review of DMFs and ensure that the DMFs complies with the ICH / USFDA / WHO / European and other applicable regulatory guidelines Responsible for receiving and responding to regulatory queries with respect to DMFs Life cycle management of DMFs -Annual Reports, Change Updates Track updates to Regulatory guidelines, Pharmacopeias and other applicable documents and guidelines and inform management and the team regularly. Responsible for handling queries regarding registration, DMFs during site audits. Responsible to review all product related documentation that goes into the DMF and / or supports the DMFs Ensure that all regulatory requirements for successful registration are addressed during development and validation – Specifications, Impurity profiles, Different regulatory requirements wrt impurities, starting materials, analytical and process validations. Responsible for reviewing and updating regulatory impact of Quality Management System events Communication and coordination with regulatory agencies for audits / audit responses / audit follow ups and any other follow ups Responsible for compilation of Open DMFs / Technical Packages for customers and other agencies Responsible to provide technical support to Business, Supply Chain regarding regulatory queries and responses from customers, suppliers and other agencies. Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc

To lead the team for Process development Process Development of drug substances To carry out lab experimentation / record documentation To generate ideas for Process Improvement of existing products and perform the required changes To lead the team for technology transfer of developed process Troubleshooting of manufacturing concerns To provide technical support to manufacturing operations To execute cost improvement plan To coordinate with other departments for troubleshooting, process improvement

Overall responsible for all type qualification and validation activity. Overall responsible for review of documents, calibration/ validation/qualification activities. Overall responsible for Inprocess Quality Assurance, TTD / PDR review / process review.Overall responsible for Vendor Qualification / vendor questionnaire/ Material management

Centralised recruitment handling experience in formulation and API Handle end-end Recruitment life cycle and have employer branding techniques Identification of Manpower requirement from HOD’s and Functional Managers; identifying candidates through multiple portals. Familiarity with Sourcing, Shortlisting, Assessment, Interview, Fitment to On-boarding Hands on experience with posting jobs on social media and job boards Reviews employment applications and background check reports Certificates verification and salary Negotiation Team player Good time-management skills Great interpersonal and communication skills Internal and external stakeholder management skills

*IPQA, Line Clearence, Blending, Sampling, BMR, BPR, Calibration, Weighing Balance, In process, cGMP

To lead the team for Process development Process Development of drug substances To carry out lab experimentation / record documentation To generate ideas for Process Improvement of existing products and perform the required changes To lead the team for technology transfer of developed process Troubleshooting of manufacturing concerns To provide technical support to manufacturing operations To execute cost improvement plan To coordinate with other departments for troubleshooting, process improvement

Responsible for ensuring cGMP compliance in the Quality Control Laboratory Responsible for establishment of policies, procedures and practices associated with laboratory activities including safety, testing scheduling and documentation Responsible to ensure the release of In-process, finished products, Raw materials, Packaging Materials Validation Sample and Stability Sample Perform trainings and supervise staff in use of instrumentation and testing techniques, protocols, procedures and ensure all QC documents to be in line with Pharmacopoeia requirements Responsible for OOS and OOT along with risk assessment Responsible for Organizing, ensuring the execution of the Calibration activities, performance verification preventive maintenance and Qualification of QC instruments/equipment’s Ensure Compliance of Analytical Method Validation, Verification and Analytical Method Transfer, API, IPFP, Stability, Excipients, Packing Material Specification, STP’s, ROA’s, RDS, Protocols Reports etc Ensure overall Compliance of Microbiological Laboratory Maintain data integrity and appropriate traceability

Managing entire span of HR Operation functions. Acts as a business partner counsels and advises team for assigned functional areas on HR issues and enables them to deliver. Serves as a key resource for legal issues and ensures local statutory compliance with federal, state and local employment laws. Managing Industrial Relations Drives Performance- and Talent Management Manages and mentors direct reports support team and involve in their developments. Handling entire employee life cycle from recruitment till exit.

Instrumentation experience in HPLC, GC, UV, IR, Analysis, Assay, Dissolution, GLP

*Liasioning, Compliance, Safety, Environment, Hazardous, Waste Management, Permit, HAZOP, License, Legal, Risk Assessment

Vendor Selection: *Keep abreast of market and continuously liaise with vendors and other industry contacts in order to maintain a rich reserve of potential vendors *Oversee and ensure process of vendor evaluation. *Approve shortlisted vendor/s before recommending to Commercial for further negotiation Vendor on-boarding and engagement: *Oversee vendor contracting process. Review terms and get sign-off. *Schedule and conduct regular vendor visits. Strategy and Cost Savings *Proactively research and recommend new/alternate vendors for production transfer/back-up to ensure on-time product delivery *Keep self and team updated with market intelligence on external manufacturing trends, vendors, prices, competitors, etc. Production Planning & Control *Discuss (Transfer) product technology and specifications with key/critical vendor/s or in cases of complex product requirements *Guide and monitor the team to ensure that the production plan is shared and executed without any delays/issues *Highlight any critical issues/delays to distribution/marketing team in order to facilitate planning

*Source candidates for various pharmaceutical roles. *Screen resumes and evaluate applicants based on job requirements, qualifications, and experience. *Coordinate interviews between candidates and hiring managers, ensuring smooth communication. *Assist in managing the recruitment process from initial contact to job offer. *Maintain candidate databases and recruitment records, ensuring up-to-date and accurate information. *Work with hiring managers to understand job requirements and develop strategies for talent acquisition. *Conduct initial phone screenings to assess candidate skills, experience, and cultural fit. *Prepare job descriptions and post job openings on various job portals and social media platforms. *Assist in onboarding processes for new hires, including preparing offer letters. *Track and report on recruitment metrics (e.g., time-to-fill, candidate sourcing, etc.). *Collaborate with the HR team to align recruitment strategies with company goals and objectives. *Stay up-to-date with trends in the pharmaceutical industry and recruitment best practices.