Role & responsibilities Job Summary: We are seeking a highly skilled and experienced professional to lead our Analytical Research & Development (ARD) team. The ideal candidate will oversee the development, validation, and transfer of analytical methods, ensure regulatory compliance, and manage ARD operations in coordination with cross-functional teams. This role involves comprehensive review responsibilities, training, project planning, and handling of regulatory and quality management systems. Key Responsibilities: Lead and manage the ARD team in day-to-day operations. Evaluate Drug Master Files (DMFs) and provide technical assessments. Oversee analytical method development; review related data including protocols, reports, and Laboratory Notebooks (LNBs). Execute and review analytical method validation for drug substances and drug products. Review and ensure compliance with Standard Operating Procedures (SOPs). Conduct and review analytical method transfers and verifications. Review all data generated within the ARD. Execute and review analytical method equivalency studies. Review and approve STPs (Standard Testing Procedures) and specifications. Establish and finalize specifications for drug substances and products. Handle and respond to regulatory queries in a timely manner. Review investigations and manage Change Control (CC) activities. Coordinate with cross-functional departments to ensure seamless project execution. Plan and conduct training and qualification for ARD personnel. Oversee in-use stability method development and validation activities. Conduct pharmaceutical equivalency studies. Plan and review ARD work allocations. Manage qualification of analytical instruments. Oversee procurement of project-specific analytical attributes. Manage software systems including e-DCS, LMS, e-Log, ERP, LIMS, and CLEEN. Investigate and manage Quality Management System (QMS) elements such as OOS (Out of Specification), OOT (Out of Trend), CC, CAPA, deviations, and incidents. Ensure adherence to Good Laboratory Practices (GLP) and Good Documentation Practices (GDP). Review periodic calibration records for all instruments. Monitor and review laboratory logbooks and records. Review User Requirement Specifications (URS) for analytical instruments. Lead CMC studies including photostability, thermal cycling, temperature excursion, and diluent studies; plan and review related protocols and reports. Execute and review analytical cleaning method validation. Participate in audit preparation and handle audit-related activities. Conduct validation using advanced analytical techniques such as ICP-MS, Malvern particle size analysis, and dissolution profiling. Conduct and support diluent studies, CMC studies, and scale-up analysis. Qualifications and Skills: Master's in Analytical Chemistry, Pharmaceutical Sciences, or a related field. Minimum 15 years of relevant experience in ARD within a pharma. Strong knowledge of ICH guidelines, regulatory requirements, and industry best practices. Hands-on experience with analytical instruments (e.g., HPLC, GC, ICP-MS, Malvern, dissolution). Proficiency in QMS systems and analytical software tools. Excellent communication, leadership, and organizational skills. Preferred candidate profile
Responsibilities Responsible for planning of daily maintenance jobs for Executive, Officers and Technicians. Responsible for verification of online records i.e. operational monitoring record and preventive maintenance record in caliber e-Log on daily basis or as per requirement. Responsible for preparation of new SOPs and revise the old SOPs. Responsible for execution of SOP training to all Executive, Officers and Technicians/ Operators. Responsible for review and analysis of critical breakdowns in plant maintenance, water system, HVAC and BMS Document. Responsible for Execution of Qualification (DQ, IQ, OQ, PQ) etc. along with QA Department. Co-ordination with external agency for Compressed air qualification, Instrument calibration and HVAC revalidation as per approved protocol and planner. Responsible for analysis of critical breakdowns and planning to reduce the repeated cause accordingly. Responsible for planning, commissioning and installation of the new plant machineries. Responsible for breakdown and preventive maintenance of plant machines. Responsible for updating the planners as per activity completion. Responsible for any new changes in the plant facility. Responsible for co-ordination with other departments for resolving Engineering related issues. Responsible for executing small projects in plant as and when required. Responsible for maintaining spare list inventories and maintaining stocks. Responsible for handling of any type of Excursion and Alarms in plant premises. Responsible to handle the QMS activities like deviation, CAPA, incident and change control observed during process. Responsible for vendor qualification. Responsible for handling of Excursion and Alarms. Responsible for compliance of e-Log, LMS and EQMS. Responsible for Audit compliance. Follow the gowning and de gowning procedure as defined in respective SOPs. Show more Show less
Greetings from Immacule Lifescience Pvt. Ltd! We are seeking experienced professionals for multiple positions in our Engineering department at our sterile injectable formulations manufacturing plant located in Nalagarh, Himachal Pradesh. Department : Engineering - Sterile Formulations Experience : 4 - 8 years Qualification : B. Tech (Electrical & Instrumentation) / Diploma (Electrical & Instrumentation) Positions Available: Officer / Executive : Plant Maintenance Engineering Executive / Senior Executive : Engineering QMS (Quality Management System) Officer : Building Management System (BMS) & Environmental Management System (EMS) Key Requirements: For plant Maintenance & QMS Hands-on experience with injectable equipment, including: - Vial Washing Machine - Vial Filling Line - Tunnel - Autoclave - Pre-Filled Syringe (PFS) Machine - Strong understanding of engineering principles and practices in a sterile manufacturing environment. How to Apply: Interested candidates can send their updated resumes to Eswar.reddy@immacule.in
Greetings From Immacule Lifesciences Pvt Ltd! We are conducting Mega Walk-In Drive for both OSD & Sterile Injectable Manufacturing on Sunday (22/06/25). Requirements: Positions : Officer to Assistant Manager Experience : 2 - 10 Years in Pharma Industry Job Location : Nalagarh, Baddi Departments: Production & Packaging OSD : ( Granulation, Compression, Coating, Capsule, Blister, Alu - Alu, Strip, AutoCartonator) Sterile : Manufacturing, Filling & Sealing, Autoclave, CNC, Vial Washing, Tunnel, Lyophilization Quality Control OSD & Sterile : Instrumental and chemical analysis i.e RM/PM/FG/ Validation/ Micro/ Stability and having competency on instruments like HPLC, GC. Quality Assurance OSD &Sterile : IPQA/QMS/Validation/Qualification/Documentation/Audit Compliance/Training/Vendor Qualification/Micro Compliance/Media Fill/PV/CV/ APQR with thorough knowledge of cGMP norms. Engineering: Sterile : Process Equipment's like Vial Washing, Vail Filling, Tunnel, Autoclave, HVAC, BMS & EMS Boiler & Water System. OSD : Plant Maintenance, HVAC, Utilities & Water System Candidates who are not able to attached the Walk-In drive, please send your resume to hr@acmegenerics.in / career@acmeformulation.com
Export documentation- Commercial Prepare the PI (PROFORMA INVOICE) according to the PO as per customer requirement. Prepare the Export Invoice & Packing List and other documents. Preparation of Post - Shipping documents for various country. Checking & preparation of Pre- shipment's documentaries according to L/C and for all payment terms. Checking Dispatch Advice according to orders and forward to Production. Co-ordinate with CHA / Freight Forwarder / Delivery Agents / Transporter for Delivery & Planning of Shipments. Keep record of monthly sales report & same to share with concern persons. Keep record of all Purchase Orders & Provide the accurate data to concern persons. Co-ordinate with the Plant of the planning for material for dispatch (export). Arranging quotes from CHA Tracking of Consignment till reaches to destination. CHA follow-up for Custom clearance, Checklist File, AWB and BL approval. Maintain Export data sheet. Arranging of Shipping documents from plant - COA, MSDS, COPP, Product approval another documents Preparing the documents for Export to send along with the goods Sending Final documents to party Banking Compliances Clear EDPMS AND IDPMS data with bank. Submit all import shipments documents in bank. Upload all shipping documents to bank portal for issuing E-brc. Arrange BRO from bank for Import shipment LC documentation Submission of original documents in Bank and follow-up Coordinate with bank for the Bank release certificate and submission of original document and clearance of BRO and sending to CHA.
Roles and Responsibilities Develop and implement quality management systems (QMS) policies, procedures, and guidelines to ensure compliance with regulatory requirements. Conduct internal audits to identify areas for improvement and implement corrective actions to address non-conformities. Prepare and maintain accurate records of quality documentation, including standard operating procedures, work instructions, and training materials. Collaborate with cross-functional teams to develop new products or processes that meet customer needs while ensuring adherence to quality standards. Ensure ongoing monitoring of production processes to detect deviations from specifications and take corrective action as needed. Desired Candidate Profile 14-20 years of experience in Quality Assurance & Regulatory Affairs with expertise in QMS implementation. Strong understanding of pharmaceutical regulations such as FDA, GMP, ISO 9001:2015 etc. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma).
Key Responsibilities: Dossier Compilation: Prepare, compile, and review regulatory submissions (CTD/ACTD format) for ROW & emerging markets. Work on Module 1 (administrative/legal), Module 2 (summaries), and Module 3 (quality) for OSD products. Ensure dossier accuracy, completeness, and alignment with country-specific requirements. Regulatory Compliance: Ensure all documentation complies with ICH , WHO , and respective country-specific guidelines . Maintain awareness of evolving regulatory requirements across ROW markets. Coordination & Liaison: Coordinate with internal teams: QA, QC, Production, Packaging, and F&D for data collation. Liaise with external stakeholders like regulatory consultants and agents for submissions and queries. Product Lifecycle Management: Manage variations, renewals, query responses, and product registration maintenance. Handle change control and post-approval regulatory activities. Document Control: Maintain updated regulatory records and submission trackers. Ensure timely and organized archiving of all submitted dossiers and correspondence.
Technical Skills: Good grasp of pharma regulatory practices, CMC, ICH guidelines, and market specific requirements (Asia, LATAM and Africa) Experience in dossier gap assessment Proven authoring capabilities in CTD and ACTD formats (Modules 1, 2, and 3) Ability to draft well-reasoned responses to client and authority queries Familiarity with ROW market-specific regulatory expectations Soft Skills: Excellent communication and writing abilities Collaborative, adaptable, and proficient in multitasking Strong time management and emotional intelligence
Roles and Responsibilities Ensure smooth operation of HVAC systems, injectable equipment, and instrumentation maintenance at USFDA facilities. Perform routine checks on plant machinery to identify potential issues before they become major problems. Troubleshoot and resolve technical issues related to PLC programming, SCADA systems, and other automated processes. Collaborate with cross-functional teams to implement new projects and upgrades in the manufacturing process. Maintain accurate records of work performed, including documentation of repairs, maintenance schedules, and inventory management. Desired Candidate Profile 7-12 years of experience in instrumentation engineering or a related field (pharmaceutical industry preferred). Diploma/B.Tech/B.E. degree in Instrumentation or Electronics & Instrumentation Engineering from a recognized institution. Strong understanding of HVAC systems, injectable equipment operation & maintenance; knowledge of pharmaceutical regulations (USFDA) an added advantage.
Gayatri Human Resources Immacule Lifesciences (P) Ltd. (Address. Village Thanthewal, Ropar Road, Nalagarh, Distt. - Solan, (H.P)-174101) Mobile No :- +91-8278729004 We are seeking a detail-oriented and proactive Regulatory Affairs Officer/Executive with hands-on experience in Oral Solid Dosage (OSD) regulatory submissions for international markets including ROW, USFDA, and MHRA . The ideal candidate will be responsible for compiling, reviewing, and submitting high-quality regulatory dossiers and ensuring compliance with the regulatory requirements of various global health authorities. Key Responsibilities: Prepare, compile, review, and submit regulatory dossiers (CTD/eCTD formats) for OSD products for USFDA, MHRA (UK), and various ROW markets . Ensure timely and accurate submission of ANDA , variation filings , renewals , and annual reports . Coordinate with cross-functional teams (R&D, QC, QA, Production, etc.) to gather necessary documentation and technical data required for submissions. Review technical documents , product development reports, validation protocols/reports, stability data, and other regulatory documents for accuracy and compliance. Maintain knowledge of regulatory requirements and guidelines for target markets (US, UK/EU, LATAM, Africa, Southeast Asia, etc.). Handle regulatory queries and deficiency letters from agencies such as USFDA and MHRA, and provide timely and effective responses. Monitor changes in regulatory requirements and assess their impact on product registration and compliance. Maintain and update the regulatory database and track submission timelines and approvals . Support in product lifecycle management and post-approval changes. Liaise with external regulatory consultants, agents, and local partners as needed for market-specific requirements. Required Skills & Competencies: In-depth knowledge of international regulatory requirements and guidelines (ICH, USFDA, MHRA, WHO, etc.). Strong experience with CTD/eCTD dossier compilation and submissions. Expertise in Oral Solid Dosage (OSD) products. Familiarity with submission platforms like ESG (FDA) , MHRA Portal , etc. Good understanding of GMP, GLP, and GDP practices. Excellent documentation , communication , and interpersonal skills . Strong attention to detail , organizational skills, and ability to manage multiple projects. Proficient in MS Office (Word, Excel, PowerPoint). Preferred Qualifications: Prior experience in a Regulatory Affairs role in a pharmaceutical manufacturing company with exposure to regulated and semi-regulated markets. Experience dealing with regulatory authorities and handling regulatory audits is a plus. Knowledge of labeling requirements , CMC documentation , and QbD submissions will be an added advantage. Gayatri Human Resources Immacule Lifesciences (P) Ltd. (Address. Village Thanthewal, Ropar Road, Nalagarh, Distt. - Solan, (H.P)-174101) Mobile No :- +91-8278729004
Role & responsibilities 1. Infrastructure Management: - Oversee the design, implementation, and maintenance of all IT infrastructure systems, including servers, networks, storage, and related hardware. - Ensure high availability and performance of critical IT systems to support 24/7 manufacturing and business operations. - Implement and maintain disaster recovery and business continuity plans to minimize downtime and ensure data integrity. 2. Security and Compliance: - Develop and enforce IT security policies and procedures to protect sensitive data and comply with industry regulations (e.g., FDA, GxP, HIPAA). - Conduct regular security assessments and audits to identify vulnerabilities and mitigate risks promptly. - Collaborate with compliance teams to ensure IT systems meet regulatory requirements and pass audits successfully. 3. Team Leadership and Development: - Lead a team of IT professionals, including system administrators and support staff, fostering a culture of collaboration, accountability, and continuous improvement. - Provide coaching, training, and mentorship to team members to enhance their technical skills and professional growth. - Manage external vendors and contractors, ensuring they deliver services and solutions that meet our standards and requirements. 4. Project Management: - Plan and execute IT projects related to infrastructure upgrades, system migrations, and technology implementations. - Define project scopes, timelines, and budgets, and ensure projects are delivered on schedule and within budget. - Evaluate emerging technologies and make recommendations for adoption based on their potential to improve efficiency or meet business needs. 5. Strategic Planning and Budgeting: - Collaborate with senior management to develop IT strategies and roadmaps aligned with business objectives and growth plans. - Prepare and manage the IT department budget, monitoring expenditures and ensuring cost-effective use of resources. - Identify opportunities to leverage technology to streamline operations and drive innovation in pharmaceutical manufacturing processes. Qualifications: - Bachelors degree in Computer Science, Information Technology, or a related field; Master’s degree preferred. - Proven experience (X years) in IT infrastructure management, preferably in the pharmaceutical or healthcare industry. - Strong knowledge of IT systems and infrastructure, including virtualization, cloud computing, and enterprise networking. - Experience with regulatory compliance requirements and IT security best practices. - Excellent leadership and communication skills, with the ability to influence and collaborate effectively across all levels of the organization. - Project management certification (e.g., PMP) is a plus. - Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.
Role & responsibilities 1. Infrastructure Management: - Oversee the design, implementation, and maintenance of all IT infrastructure systems, including servers, networks, storage, and related hardware. - Ensure high availability and performance of critical IT systems to support 24/7 manufacturing and business operations. - Implement and maintain disaster recovery and business continuity plans to minimize downtime and ensure data integrity. 2. Security and Compliance: - Develop and enforce IT security policies and procedures to protect sensitive data and comply with industry regulations (e.g., FDA, GxP, HIPAA). - Conduct regular security assessments and audits to identify vulnerabilities and mitigate risks promptly. - Collaborate with compliance teams to ensure IT systems meet regulatory requirements and pass audits successfully. 3. Team Leadership and Development: - Lead a team of IT professionals, including system administrators and support staff, fostering a culture of collaboration, accountability, and continuous improvement. - Provide coaching, training, and mentorship to team members to enhance their technical skills and professional growth. - Manage external vendors and contractors, ensuring they deliver services and solutions that meet our standards and requirements. 4. Project Management: - Plan and execute IT projects related to infrastructure upgrades, system migrations, and technology implementations. - Define project scopes, timelines, and budgets, and ensure projects are delivered on schedule and within budget. - Evaluate emerging technologies and make recommendations for adoption based on their potential to improve efficiency or meet business needs. 5. Strategic Planning and Budgeting: - Collaborate with senior management to develop IT strategies and roadmaps aligned with business objectives and growth plans. - Prepare and manage the IT department budget, monitoring expenditures and ensuring cost-effective use of resources. - Identify opportunities to leverage technology to streamline operations and drive innovation in pharmaceutical manufacturing processes. Qualifications: - Bachelors degree in Computer Science, Information Technology, or a related field; Master’s degree preferred. - Proven experience (X years) in IT infrastructure management, preferably in the pharmaceutical or healthcare industry. - Strong knowledge of IT systems and infrastructure, including virtualization, cloud computing, and enterprise networking. - Experience with regulatory compliance requirements and IT security best practices. - Excellent leadership and communication skills, with the ability to influence and collaborate effectively across all levels of the organization. - Project management certification (e.g., PMP) is a plus. - Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.
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