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3.0 - 6.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Execution of production plan for formulation and filling. 2. Achieving planned FP targets with strict adherence to cGMP. 3. Execution of planned activities of Aseptic Processing Areas like media fills simulation trails, Formulation and filling activities. 4. Ensuring of sterilizing loads, cleanliness of filling room, entry and exit change rooms of aseptic areas. 5. Preparing and implementation of standard operating Procedures, Protocols, cleaning procedures and relevant log sheets. 6. On-line execution of Batch documents and related logbooks. 7. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 8. Maintaining documents as per regulatory and cGMP norms. 9. Performing day to day activities in manufacturing areas. 10. Reporting all the activities, incidents and issues to Reporting Manager. 11. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 12. Handling of SAP and DMS as per the requirement.
Posted 2 weeks ago
2.0 - 5.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Monitoring of area drains cleaning and documents updation. Updation of area / equipment status labels. Samples handling (Sampling and labelling). Arrangement of material required for activities. Assisting in Execution of production activities. Updation of BMR's. Receiving material (RM miscellaneous). Returning miscellaneous materials to warehouse. Planning and Execution of FDS thawing and dispensing activities. Assisting in product changeover activities before batch execution. Assisting column packing and execution of equipment specific protocols. Assisting in Equipment (Purification TFF system) cleaning.
Posted 2 weeks ago
9.0 - 11.0 years
3 - 7 Lacs
Hyderabad, Jadcherla
Work from Office
1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOPs related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipments. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer
Posted 2 weeks ago
7.0 - 10.0 years
3 - 7 Lacs
Hyderabad, Jadcherla
Work from Office
Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia , including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines . Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions . Manage regulatory responses to queries and deficiency letters from health authorities and clients , ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections , tender submissions , and related regulatory filings. Stay updated with regional regulatory developments , including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatorySOPs and documentation standards .
Posted 2 weeks ago
8.0 - 12.0 years
3 - 7 Lacs
Hyderabad, Jadcherla
Work from Office
Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings. Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatory SOPs and documentation standards.
Posted 2 weeks ago
0.0 - 1.0 years
2 - 2 Lacs
Jadcherla
Work from Office
Responsibilities: * Conduct microbial testing on products * Analyze test results and report findings * Maintain accurate records and documentation * Collaborate with R&D team on product development Health insurance Performance bonus Gratuity Provident fund
Posted 2 weeks ago
5.0 - 11.0 years
3 - 6 Lacs
Jadcherla
Work from Office
The incumbent should be an acknowledged leader in legal education, good team builder, team player and team leader. He should have a perspective & a vision for taking forward the new school set up one year back. He should have strong academic and administrative skills. He should be a good communicator and should have a command in his field of expertise. Preference will be given to candidates who have experience of setting up Law School at national level. He should have good network at National & International level. He/She shall be completely responsible for running the programmes, which includes formulating strategies, curriculum design & development, monitoring teaching-learning processes, academic coordination, placements support and Industry Institute collaboration. The incumbent should have a Ph. D from a reputed University/Institute with 15 years of Academic and Administrative experience in the field. Should have strong linkages & network with the industry & academics. Should be well acquainted with the various Accreditation Agencies and Statutory bodies and the procedures.
Posted 3 weeks ago
10.0 - 16.0 years
8 - 18 Lacs
Jadcherla
Work from Office
Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience
Posted 3 weeks ago
0.0 - 5.0 years
1 - 6 Lacs
Jadcherla
Work from Office
Role & responsibilities Jr. Operator / Operator / Sr. Operator Vial washing, Depyrogenation, HPHV Steam Sterilizer, Production related activities Experience: 0 - 6 years Qualification ITI/Diploma/B.Sc/Equivalent Officer / Executive Production plan, filling activities, cGMP, SOP, Preventive maintenance, Lyophilizer, Aseptic Media fills, HPHV, Handling Filter integrities, DQ, IQ, PQ, OQ. Experience: 0 - 6 years Qualification B. Pharmacy / M. Pharmacy Asst. Manager / Manager QMS, SOPs, cGMP, DQ,IQ ,PQ, OQ Preventive Maintenance, filling activities, Training plan schedules. Experience 9-15 Years Qualification B. Pharmacy / M Pharmacy Preferred candidate profile Preferrable Injectable / Biological Production Experience
Posted 3 weeks ago
4.0 - 9.0 years
10 - 20 Lacs
Jadcherla
Work from Office
Strong in SAP, Excel, Good in Communication Looking for Plant Commercial Head to oversee Commercial Activities, Accounting, and GST. The candidate will have a strong background in commercial operations, accounting, and statutory compliances.
Posted 4 weeks ago
0.0 - 1.0 years
3 - 5 Lacs
Jadcherla
Work from Office
YOU WILL BE WORKING DIRECTLY WITH THE COO (Chief Operating Officer) AND ASSISTING HIM TO MANAGE VARIOUS PROJECTS AND IMPLEMENTATION ACTIVITIES The role involves documentation management, project coordination, and ensuring quality/compliance. You will collaborate on operational efficiency and process improvements, gaining hands-on experience in manufacturing, documentation, and SOPs. The role involves documentation management, project coordination, and ensuring quality/compliance. Ideal candidates are adaptable, quick learners with strong problem-solving skills. Responsibilities: Assist in monitoring and optimizing manufacturing processes to ensure efficiency and compliance with quality standards in OSD formulation. Ensuring adherence to Evertogen Life Sciences' SOPs. Assist in the review and approval of batch manufacturing records to ensure compliance Support the implementation of corrective and preventive actions (CAPA) to address quality issues identified through internal audits. Support the investigation of out-of-specification (OOS) results and implement corrective actions to maintain product integrity. General Expectations: Demonstrated understanding of pharmaceutical manufacturing processes and quality control principles. Proficiency in technical documentation and report writing, with keen attention to detail. Excellent communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams. Ability to adapt quickly to new situations and learn new skills in a fast-paced environment.
Posted 4 weeks ago
2.0 - 6.0 years
4 - 8 Lacs
Jadcherla
Work from Office
Role & responsibilities Set up and operate foam filling equipment according to production requirements. Capable to do the changeover and run the automatic foam filling machine. Monitor filling levels, pressure, and temperature to ensure consistent quality. Inspect filled products for defects, leaks, or inconsistencies. Maintain accurate production records and log material usage. Conduct routine maintenance and report equipment malfunctions. Follow safety and environmental procedures, including proper use of PPE. Keep the work area clean and organized. Preferred candidate profile Experience in a manufacturing or chemical handling environment is an advantage. Ability to operate and troubleshoot machinery. Good attention to detail and ability to follow instructions.
Posted 4 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Jadcherla
Work from Office
Analytical Method Development & Validation : Develop and validate analytical methods for assay, dissolution, related substances, and content uniformity as per ICH guidelines. Troubleshoot and optimize analytical methods for new and existing OSD products (tablets, capsules, etc.). Routine Analysis & Documentation : Conduct analysis of raw materials, in-process samples, and finished products. Prepare and review protocols, reports, method validation documents, and specifications. Stability Studies : Execute and monitor stability studies as per ICH guidelines. Generate stability data and interpret results to support product registration. Instrumentation Handling : Operate and maintain sophisticated analytical instruments like HPLC, UV, FTIR, Dissolution Apparatus, GC, etc. Ensure proper calibration and upkeep of instruments. Regulatory Compliance : Ensure all analytical activities comply with GLP/GMP and regulatory requirements. Support regulatory submissions (ANDA, CTD, eCTD) with analytical documentation. Cross-functional Support : Collaborate with formulation, regulatory, QA, and production teams to support product development lifecycle. Participate in technology transfer and scale-up activities. Key Skills : Sound knowledge of analytical chemistry and pharmaceutical analysis. Hands-on experience with HPLC/GC/UV and dissolution testing. Familiarity with ICH guidelines and regulatory requirements for US/EU/ROW markets. Good documentation practices and data integrity awareness. Ability to work in a fast-paced, cross-functional environment.
Posted 4 weeks ago
1.0 - 2.0 years
1 - 4 Lacs
Jadcherla
Work from Office
Installation: Install heating, ventilation, air conditioning, and refrigeration systems in new construction projects or existing buildings. Follow blueprints, specifications, and local building codes to ensure proper installation and functionality. Maintenance: Perform routine maintenance tasks, including cleaning, lubricating, and inspecting HVAC/R systems and components. Replace filters, belts, motors, and other worn or damaged parts as needed to ensure optimal performance and energy efficiency. Repair: Diagnose and troubleshoot HVAC/R systems to identify malfunctions, leaks, or performance issues. Repair or replace defective components, such as compressors, coils, thermostats, and valves, using hand tools, power tools, and specialized equipment. System Optimization: Calibrate controls, adjust settings, and fine-tune HVAC/R systems to maximize efficiency, comfort, and performance. Recommend upgrades or modifications to improve system reliability and energy efficiency. Refrigerant Handling: Handle, recover, recycle, and recharge refrigerants in compliance with EPA regulations and industry best practices. Ensure proper handling and disposal of refrigerants to prevent environmental contamination and comply with safety standards. Customer Service: Interact with customers, building owners, and property managers to assess their HVAC/R needs, provide recommendations, and address concerns. Communicate effectively and professionally to build positive relationships and ensure customer satisfaction. Safety Compliance: Follow safety protocols, guidelines, and regulations to prevent accidents, injuries, and property damage during HVAC/R installation, maintenance, and repair activities. Use personal protective equipment (PPE) and adhere to safety procedures at all times. Documentation: Maintain accurate records of HVAC/R service calls, inspections, repairs, and maintenance activities. Document equipment readings, test results, and recommendations for future reference and compliance purposes.
Posted 4 weeks ago
0.0 - 4.0 years
1 - 2 Lacs
Jadcherla
Work from Office
Jha Home Tuition is looking for Home Tutor to join our dynamic team and embark on a rewarding career journey Provide personalized academic support Develop lesson plans based on student needs Assess progress and provide feedback Maintain a structured learning environment
Posted 1 month ago
5.0 - 10.0 years
6 - 10 Lacs
Jadcherla
Work from Office
Responsibilities Operational excellence Lead and ensure execution of reliability excellence/maintenance programs. Create and maintain reliability maintenance strategy documents. • Implement Lean manufacturing tools to empower employees and facilitate growth to ensure improvement of the financial performance, in collaboration with Maintenance Planners/Supervisors Rank the criticality of the assets using reliability Centred Maintenance approaches and define proactive maintenance approaches that are cost-beneficial to the business. Identify and implement predictive maintenance technologies. Perform/support operational event and equipment failure investigations to determine effectiveness and to ensure that the root cause/causal factors are identified, corrective actions are prescribed, and follow-up monitoring is conducted. • Conduct program and system/equipment audits (safety, risk, compliance,) on a periodic and as needed basis. Participate in the planning, design review, value management and construction document development of new facilities and renovations. Support utility distribution, master planning, and business continuity planning. Perform life-cycle financial modelling of developed technical solutions. Construct detailed technical proposals and draft bid documents. Support commissioning activities for all upgrade, renovation, and construction projects which may include, but is not limited to, PM job plans, reviews for maintainability, critical spares, documentation, etc. Analysis and KPI Reporting • Develop, manage and monitor KPIs and ensure optimal reporting : • Develop and maintain new KPIs of equipment reliability. Lead in maintenance improvement tools (PM Optimization, RCM, RCA, RCFA, FMEA, etc.) and knowledgeable in predictive maintenance tools (Vibration, Ultrasound, Thermography, etc). Maintain a high level of technical competency in advanced maintenance technology. • Maintain equipment repair history and evaluate repair costs & trends. Analyse equipment failure data patterns and interpret ERP PM maintenance data to generate priorities and action lists for improving reliability of site . • Track the performance of reliability improvements to determine their effectiveness and make additional modifications if required. By working closely with the Maintenance Planners, use intervals for potential failures to appropriately prioritize, plan, and schedule to minimize downtime. Develop solutions for repetitive, chronic, or costly failures and other maintenance problems, and apply value analysis to repair/replace, repair/redesign, and make/buy decisions. Assist in troubleshooting techniques for major/repetitive equipment. Monitor and report on all relevant maintenance activity KPIs including wrench time analysis. Deliver VCO savings. Support maintenance department Advise and support the Maintenance Supervisors/Managers Roll out learnings and workshops and take an active role Improve quality of maintenance by improving CIP culture by implementing SMPs, SMED analysis as well as follow up on critical production processes and expensive and repetitive maintenance jobs for RCFA Follow up and solve small technical problems Reduce administration workload in PM organization (reporting, communication, automize administration, reduce waste in administration, ) Coordinate 3th party services according to Sibelco technical and safety standards Safety Knowledge of Sibelco's safety regulations and ensure activities are in compliance with those regulations. Spare Parts & services Ensure adequate and cost-effective procurement of high quality maintenance supplies, in close collaboration with the procurement department of Sibelco. Use warehouse system to perform maintenance planning and support maintenance manager in stock strategy Use warehouse system to provide correct parts and tools and set-up correct stock parameters according criticality analysis Advise in stock parameters in collaboration with maintenance manager Create purchase order for necessary parts and services Contact suppliers to ensure correct parts and services are delivered as promised to execute the jobs as planned Planning & Prioritizing Accurately determines the complexity of tasks and projects and required resources Breaks down projects or assignments into different steps (group of activities) Sets priorities and time parameters to accomplish tasks and projects Coordinates efforts to implement plan Optimizes Work Processes Actively uses the practices, processes, and procedures within the operating model to get things done Organises people and activities for simple and complex processes in an effective way Looks for opportunities to improve the way of working Collaborates Consistently fosters collaboration across the organisation Builds strong inclusive relationships across Business/Functions and levels Inspires individuals and maximise team dynamics to achieve common goals. Drives Engagement Enables and empowers people to give their best Makes the link between what drives people and the organisational goal Makes each Sibelco employee feel that their contributions are important Managing Change & Ambiguity Stays composed and navigates through change effectively Leads others to operate effectively in absence of clear structure and processes Comfortable in making decisions and taking actions, even with incomplete information Handles risk and uncertainty comfortably (Technical) Capabilities Industry knowledge Practical understanding of mineral processing equipment and processes Technical knowledge Understanding the variety of processes executed at Sibelco in such a way that creative solutions can be found. Experience with predictive maintenance technologies including, but not limited to, vibration analysis, oil analysis, infrared Thermography, ultra-sound and motor current analysis. Experience with Root Cause Failure Analysis, Equipment Criticality Ranking, Preventive Maintenance (PM) and Condition Based Maintenance (CBM). People skills Efficient and clear communication Ability to motivate the team Coaching people Change management skills IT knowledge Knowledge of MS Office, SAP, Mendix, reporting tools, technical software Engineering skills Comprehensive knowledge of engineering principles applied to design, operation and maintenance of building structures and mechanical and electrical equipment for buildings. Excellent working knowledge of the facilities maintenance subject area, knowledge of the workforce and supplier capabilities as well as an awareness of progressive developments within the industry. Behavioural skills Open minded Team player Pro-active Analytical Able to work independently Self-motivated Good communication across different organizational levels
Posted 1 month ago
1.0 - 2.0 years
1 - 2 Lacs
Jadcherla
Work from Office
Good sound in LT , PT , TT & RTD Weigh scales & Filling stations. Pneumatic ON/OFF valves & Control valves LT,PT calibration. Basic knowledge in troubleshooting PLC. Foundation field bus knowledge.
Posted 1 month ago
8.0 - 10.0 years
6 - 8 Lacs
Jadcherla
Work from Office
Roles and Responsibilities Site Safety Supervision Monitor daily site activities to ensure compliance with safety standards and procedures. Conduct routine site inspections to identify potential hazards and ensure corrective actions are taken. 2. Implementation of Safety Policies Assist in the development and implementation of safety policies, procedures, and protocols in accordance with local laws and company standards. Ensure adherence to health, safety, and environmental (HSE) regulations. 3. Emergency Preparedness Ensure availability and maintenance of first aid kits, fire extinguishers, and emergency equipment. Participate in emergency drills and ensure staff are aware of emergency procedures. 4. PPE Monitoring and Compliance Enforce the proper use of Personal Protective Equipment (PPE) on site. Ensure the availability and condition of PPE for all workers. 5. Training and Awareness Conduct safety induction and orientation programs for new employees and contractors. Organize regular safety training and toolbox talks for workers on risk awareness and safe work practices. Educational Qualifications: Bachelors Degree (required): Preferably in Engineering , Science , Chemistry , or Environmental Science . Candidates from B.Sc. (Chemistry/Physics) or Diploma in Engineering backgrounds are also common. Additional Safety Certifications (highly recommended or required depending on the industry): Diploma in Industrial Safety (recognized by State Technical Boards or the Factories Act). NEBOSH (National Examination Board in Occupational Safety and Health – UK based). IOSH (Institution of Occupational Safety and Health – UK). OSHA certification (for those working in international environments or MNCs). Fire Safety Training , First Aid Training , Hazardous Waste Management , etc.
Posted 1 month ago
0.0 - 5.0 years
1 - 6 Lacs
Jadcherla
Work from Office
Role & responsibilities Having Knowledge to Handle Parenteral drug product visual inspection & Packing activities Equipment operation and supervise the visual inspection, Batch packing execution, SOP, cGMP, MPR, BPR, QMS Preferred candidate profile
Posted 1 month ago
10.0 - 13.0 years
11 - 13 Lacs
Jadcherla
Work from Office
Role & responsibilities Role: Production Planning & Inventory Control (PPIC) Specialist/Manager/Engineer (depending on the level). Objective: To ensure efficient and timely production of injectable products by effectively planning production schedules, managing inventory levels, and coordinating with other departments to meet production targets and customer demands. II. Key Responsibilities: Production Planning: Develop and maintain production schedules based on sales forecasts, customer orders, and production capacity. Ensure timely availability of raw materials, packaging components, and other necessary resources. Optimize production processes to minimize waste and maximize efficiency. Manage production capacity and resource allocation to meet production targets. Monitor and analyze production performance to identify areas for improvement. Coordinate with other departments, such as procurement, quality control, and manufacturing, to ensure smooth production operations. Plan for new product launches and process changes. Ensure compliance with regulatory requirements (e.g., cGMP). Inventory Control: Manage inventory levels of raw materials, work-in-progress, and finished goods. Implement and maintain inventory control systems to ensure accurate stock levels and minimize stockouts or overstocking. Monitor inventory turnover and identify slow-moving or obsolete items. Coordinate with the warehouse and logistics teams to ensure efficient storage and retrieval of materials. Maintain accurate inventory records and reports. Conduct periodic inventory counts and reconciliations. Optimize inventory storage and handling processes. Coordination & Communication: Collaborate with sales, marketing, and customer service teams to understand customer demands and ensure timely delivery of products. Communicate production plans and schedules to relevant stakeholders. Resolve production issues and address any supply chain disruptions. Participate in cross-functional meetings and projects. III. Skills Strong analytical and problem-solving skills. Excellent organizational and planning skills. Proficiency in ERP/MRP systems (e.g., SAP, Oracle). Knowledge of inventory management principles and practices. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Knowledge of cGMP and other relevant regulations. Experience with data analysis and reporting tools. Familiarity with pharmaceutical manufacturing processes (e.g., aseptic processing, formulation, packaging). IV. Additional Notes: The specific responsibilities and requirements may vary depending on the size and complexity of the organization. This job description is a general guideline and may be subject to change
Posted 1 month ago
15.0 - 20.0 years
15 - 20 Lacs
Jadcherla
Work from Office
Role & responsibilities: Responsible for all the activities starting from RM dispensing till the products reaches the packing stage. To approve the instructions relating to production operations (SOPs & Batch manufacturing) and ensure their strict implementation. To ensure that the production operations are carried out as per cGMP regulations, required initial and continuing training of the department personnel. To ensure that requisite documentation like monthly stock statements, production reports are made. Preferred candidate profile: Education: B. Pharmacy or M. Pharmacy Experience: 15-20 years in Pharmaceutical Production with proven experience in Derma (Ointment, Cream, Lotion, Gel) Regulatory Manufacturing facility. Strong Leadership, People Management, Experience in Regulated markets (USFDA) is essential.
Posted 1 month ago
6.0 - 8.0 years
0 Lacs
Jadcherla, Telangana, India
On-site
Job Title: Assistant Manager – Regulatory Affairs Operations (Biopharma – Asia Region) Department: Regulatory Affairs Reports To: General Manager – Regulatory Affairs Job Summary: We are seeking a motivated and detail-oriented Assistant Manager – Regulatory Affairs Operations to manage and support regulatory submissions, product lifecycle activities, and compliance for biopharmaceutical products across the Asia region. The ideal candidate will have a sound understanding of regional regulatory requirements, experience with dossier preparation and post-approval activities, and strong technical expertise in biologics, biosimilars, and analytical methods. Key Responsibilities: Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings. Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatory SOPs and documentation standards. Requirements: Postgraduate degree in Life Sciences, Biotechnology, Pharmacy, or a related field. Minimum 6-8 years of regulatory affairs experience, with a strong focus on biopharmaceutical products in the Asia region. Deep knowledge of country-specific regulatory frameworks . Proficient in CTD and ACTD dossier formats. Understanding of ICH guidelines and biosimilar regulatory pathways. Strong technical knowledge in analytical methods, bioprocesses, and quality documentation for biologics. Experience with GMP audit documentation, regulatory inspections, and health authority interactions. Excellent organizational, communication, and project management skills. Interested candidates can send CV to prathap.s@hetero.com
Posted 1 month ago
1.0 - 6.0 years
3 - 8 Lacs
Jadcherla
Work from Office
Role & responsibilities Jr. Operator / Operator / Sr. Operator Vial washing, Depyrogenation, HPHV Steam Sterilizer, Production related activities Experience: 1 - 6 years Qualification ITI/Diploma/B.Sc/Equivalent Officer / Executive Production plan, filling activities, cGMP, SOP, Preventive maintenance, Lyophilizer, Aseptic Media fills, HPHV, Handling Filter integrities, DQ, IQ, PQ, OQ. Experience: 1 - 6 years Qualification B. Pharmacy / M. Pharmacy Asst. Manager / Manager QMS, SOPs, cGMP, DQ,IQ ,PQ, OQ Preventive Maintenance, filling activities, Training plan schedules. Experience 9-15 Years Qualification B. Pharmacy / M Pharmacy Preferred candidate profile Preferrable Injectable / Biological Production Experience
Posted 1 month ago
13.0 - 20.0 years
15 - 25 Lacs
Jadcherla
Work from Office
Greetings from Hetero Labs Limited.!! We have an urgent opening for the formulation Unit VI (Injectable) @ Jadcherla, Mahabubnagar. Job Title: Injectable Plant Compliance Manager Location : UNIT VI, Jadcherla Company: Hetero Labs Limited Job Type : Full-time Reporting too To: Plant Head Qualification: B.Pharma, M.Sc & M.Pharma (Pharmacy, Life Sciences, Engineering, or a related field) Experience: Minimum of 15yrs+ of experience in the pharmaceutical industry, with a focus on injectable products. Strong knowledge of regulatory requirements for injectable pharmaceuticals (FDA, EMA, etc.). Job Description: We are seeking a motivated and detail-oriented Injectable Plant Compliance Manager to join our team. The ideal candidate will be responsible for ensuring compliance with all regulatory requirements and industry standards specific to the production of injectable pharmaceutical products. This role will serve as a key leader in maintaining quality assurance, overseeing audits, and implementing compliance systems to ensure the safety and efficacy of our products. Key Responsibilities: Regulatory Compliance: Ensure adherence to current Good Manufacturing Practices (cGMP), FDA regulations, and other applicable industry standards relevant to injectable products. Maintain up-to-date knowledge of regulatory changes affecting the injectable pharmaceutical industry. Quality Assurance: Develop, implement, and maintain compliance programs and quality management systems. Lead investigations for non-compliance events, deviations, and product recalls, ensuring timely resolution and corrective actions. Inspections and Audits: Prepare for and conduct internal audits and inspections to assess compliance with corporate and regulatory policies. Coordinate and manage external inspections (e.g., FDA, EMA) and respond to observations and findings. Training and Development: Develop and deliver training programs for staff on compliance policies, procedures, and best practices. Foster a culture of quality and compliance throughout the plant. Documentation and Reporting : Oversee the preparation and maintenance of Quality Systems documentation, including SOPs, change controls, and validation protocols. Compile and report on compliance metrics and trends to management and relevant stakeholders. Cross-Functional Collaboration: Collaborate with production, engineering, and R&D teams to ensure compliance is integrated into all aspects of operations. Act as a liaison between the plant and regulatory agencies, ensuring clear communication regarding compliance matters. Continuous Improvement: Identify areas for improvement in compliance processes and lead initiatives to enhance operational efficiency and safety. Stay informed about industry best practices and integrate them into the plants compliance strategies. Proven experience in quality assurance, compliance management, and auditing within a manufacturing environment. Excellent organizational, analytical, and problem-solving skills. Strong communication and interpersonal skills with the ability to collaborate effectively across departments. Proficient in MS Office Suite and compliance management software. Specific Skills and Experience: Knowledge of GMP, GLP, and other relevant regulatory guidelines. Experience in sterile manufacturing and aseptic processing. Proficiency in documentation management and record-keeping. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Experience in handling change control, deviations, and CAPA. Understanding of formulation development and process optimization Preferred Skills: Certification in quality management (e.g., ASQ, ISO) or relevant regulatory compliance. Experience with risk management and mitigation strategies in a pharmaceutical context. Familiarity with electronic documentation systems like Trackwise or equivalent. Note: These roles require a strong understanding of pharmaceutical science, regulatory compliance, and manufacturing processes to ensure the safe and effective production of injectable medications. Email : Harishwar.m@hetero.com ( Subject: Production Injectable Plant Compliance ) Cont: 8121005416 for further info.
Posted 1 month ago
2.0 - 7.0 years
3 - 7 Lacs
Jadcherla
Work from Office
HIRING FOR FORMULATION UNIT - INJECTABLE/ OSD JOB DESCRIPTION AND EXPERIENCE: WORK LOCATION: Hetero Labs Limited, UNIT V & VI, Polleypally, Jadcherla, Mahabubnagar PRODUCTION(OSD) Experience: (02-07Years) Compression, Granulation, Coating, Capsule filling, Inspection PRODUCTION (INJECTABLE) Experience: (02-07Years) Autoclave, Compounding, filling, QMS, Vial Washing, Lyophilizer, Visual Inspection PACKING (INJECTABLE/OSD) Experience: (01-05Years) Blister Packing, Bottle Packing. QC & QC- Micro Experience: (02-07Years) HPLC, GC, RM,PM, Stability, IP/FP,MLT, Environmental monitoring, QA-INJECTABLE Experience: (02-07Years) IPQA, Validation, Qualification, CSV, AQA (QC & Microbiology) WAREHOUSE Experience: (01-07Years) Raw Material, Packing Material, Finished Goods QUALIFICATION : I.T.I, Diploma, B.Com, B.Sc, B.Tech, B. Pharm, M.Sc with relevant experience DESIGNATIONS: Operator, Sr.Operator, Jr.Officer, Officer, Jr.Executive, Executive & Sr. Executive INTERVIEW VENUE: Hotel: UJWALA GRAND Gandimaisamma, gandimaisamma- Medak Road, Hyderabad, Telanagana- 500043 DATE &TIME: 28th & 29th June'2025 (Saturday & Sunday); From 09.00 A.M. to 03.00 P.M NEED TO CARRY: Resume, 3 Month Pay slips, Increment letter, Previous company relieving letters, Education Documents and ID Proofs Help Us Spread the Word (Refer): Circulate it in your Social Networking sites and groups for better reach and Refer your friends and colleagues, it could be a great opportunity for someone in need! CONTACT INFO: E-mail: Harishwar.m@hetero.com & Cont: 8121036004 for further info
Posted 1 month ago
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