71 Mhra Jobs - Page 2

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Sr Executive LLM (NPD) Job Requisitions No : 9102 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 380054 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Executive Regulatory Affaris Job Requisitions No : 13246 Job Description Purpose of Job The purpose of the job is to take the responsibility of Dossier requests received from internal business partners, Skill Required Experience of handling registrations of biosimilars in regulated and semi regulated markets, Experience of drafting dossier sections Experience of drafting query responses Experience of interactions and co-ordination with CFTs Strong communication skills Experience of handling RA tools Roles and Responsibilites Summary Of Job Functions Responsible for preparation of regulatory submissions (regulated and semi regulated markets) Key Responsibilities Responsible for authoring IMPD and MAA by collating all the documents for registration of biosimilar products in regulated market EU/US/ROW regions Preparation of scientific advice and briefing book documents for biosimilars Preparation of responses to queries received from various regulatory agencies To work within regulatory teams for effective preparation of CMC documents for regulated and semi regulated markets, Updating and maintaining the regulatory trackers with the required details Provide necessary regulatory assessment for change controls Qualification Required Pharm/B Biological experience is added advantage/preferable Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills

Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills

Long Description Assign and coordinate with external vendors and execute the HVAC & Utilities validations as per planned schedule with coordination of user departments. Develop good rapport with external agencies to ensure validation of system is in place on time and ability to lead team of 5 to10 members. Develop and maintain accurate, efficient HVAC & Utilities operational and validation procedures. Keep abreast of the latest amendments as per ISO14644 and other regulatory standards. Implementation and review of departmental documentation & QMS activities. Shall have Hands-on experience on Change Control Management, Investigations & CAPA modules. Tracking allocated QMS task completion and closer within time. Lead continuous improvement initiatives in the HVAC & Utilities to increase process efficiency, energy conservation and capacity while maintaining a high level of quality. Should have hands on experience in HVAC / BMS / EMS / Air compressors / Air Dryers/ Heat Pumps /Brine chillers / Chillers / Cooling Towers etc. Analysis of breakdown notifications. Maintaining and procurement of critical spare parts. Preparing and renewal of annual maintenance contracts with external agencies. Maintaining UPS & electrical panels in safe and compliance condition. Ensure compliance to cGMP and quality system. Develop and train the HVAC & Utility staff on procedures and validations. Having exposure to face the regulatory auditors like USFDA, MHRA, ANVISA and TGA etc. Prepare the budget and capex for the engineering department and monitoring of yearly expenditure of engineering department. Legal compliance with respect to safety & environment, licensing with government authorities. Competencies 3. Customer Centricity 2. Innovation & Creativity 6. Process Excellence 8. Stakeholder Management 4. Developing Talent 7. Collaboration Education B. Tech Diploma in Mechanical Engineering or Electrical Work Experience 6 to 8 Years in Injectable HVAC & Utilities lead position

Experience Required: Diploma in engineering/ D.Pharma with 1-2 years of experience in core compression area Exposure to Korsch XT 600 compression machine candidate shall be preferred. Should have expertise in compression department also Should have exposure in machine installation qualification activity. Should have exposure to regulatory audits such as MHRA, USFDA etc. Person working in a containment facility are preferred. Followings will be the responsibilities of the position holder: 1. Responsible for Operation, cleaning and primary maintenance of AWC based compression machine. 2. Competent for (entry) recording of activity in logbooks, Batch manufacturing record Responsible for completing documentation as required in the manufacturing of product and the cleaning of facilities and equipment, following cGMP s and good documentation practices. 3. To perform all in-process checks and monitoring of all intermediate processes in compression, to prepare new recipes set process parameters in PLC/SCADA as per BMR ensure its correctness before Compression machine run. 4. Issuance, utilization, cleaning, polishing, buffing and retrieval of tablet tooling (Die punches) Proper handling of machine change parts with its inventory. 5. Responsible for set up, changeover, and operation of various manufacturing equipment s but not limited to compression department. 6. Ability to read, write and communicate in English, Strong work ethic, professional approach, and ownership of lines production performance. 7. Ability to read understand SOP s, Batch Records, training documents Basic computer knowledge. 8. Ensures accurate and timely completion of all equipment logs and documentation. Understands and adheres to all cGMP and FDA regulations. 9. Responsible for reporting and/or escalating any conditions or problems that may affect the quality or integrity of product to supervisor and HOD production. 10. Responsible for maintaining a neat, clean and safe working environment at all times and notifies supervisor immediately of any safety concerns, accidents or injuries are observed. 11. Understands and adheres to all Company policies, procedures, SOPs and Safety regulations. 12. Willingness to do overtime as needed responsible for performing additional task, related duties as assigned. 13. Responsible for completing all training requirements and maintaining 100% compliance with all assignments.

Key Responsibilities: Leadership Team Management: Lead and mentor the QC team, ensuring efficient workflow and compliance. Review Approval of Analytical Documents: Oversee Analytical Reports, COAs, Method Validations, and Instrument Calibration Records. Analytical Expertise: Extensive experience in Wet Chemical Analysis, Instrumental Techniques (HPLC, GC, FTIR, UV, Auto Titration, Particle Size Analysis, etc.). Quality System Management: Handle Out of Specification (OOS), Out of Trend (OOT), Deviation Investigations, CAPA Implementation. Regulatory Compliance: Ensure adherence to GMP, GLP, ICH, WHO, FDA, and EU-GMP guidelines. Preparation of SOPs, Specifications, and STPs: Develop and maintain robust quality control procedures. Handling QMS Documents: Oversee Change Control, Market Complaints, Incidents, and Laboratory Investigations. Audit Readiness Compliance: Provide responses and corrective actions for regulatory audits (USFDA, WHO, EU-GMP, MHRA, etc.). Cross-Functional Collaboration: Work closely with Production, RD, and Quality Assurance teams to drive continuous improvements. Required Skills: Strong leadership problem-solving skills. Expertise in API Quality Control, including chemical and instrumental analysis. Proficiency in Regulatory Compliance QMS Documentation. Excellent communication team management capabilities. Hands-on experience in CAPA, Deviation Management, and Analytical Method Validations. Exposure to handling regulatory inspections audit preparations.

Key Responsibilities: Perform Routine Wet Chemical Analysis - Assay Titration, Loss on Drying (LOD), Sulphated Ash, pH Measurement, Solubility Testing. Instrumental Analysis - Hands-on experience with FTIR, UV, HPLC, GC, and Auto Titration. Sampling Testing of Raw Materials, In-Process, and Finished Products. Preparation Standardization of Volumetric Solutions. Review Maintenance of Analytical Documentation - Analytical Reports, Logbooks, and COAs. Conduct Stability Studies Method Validations. Basic Troubleshooting Calibration of Analytical Instruments. Ensure Compliance with GMP, GLP, and Regulatory Requirements. Required Skills: Strong understanding of wet instrumental analysis. Hands-on experience in Analytical Techniques - FTIR, UV, HPLC, GC, Auto Titration. Knowledge of Regulatory Guidelines - ICH, WHO, FDA, EU-GMP. Understanding of Quality Management Systems (QMS) Data Integrity. Ability to handle Out of Specification (OOS) Out of Trend (OOT) investigations. Good communication documentation skills.

Experience Required: B.Pharm / M. Sc. with 1-4 years of experience in Micro QC. Approved chemist licensed candidate shall be preferred. Well versed with CAPA, GMP Documentation, should have exposure to regulatory audits such as MHRA, USFDA etc. Followings will be the responsibilities of the position holder: To perform media preparation, sterilization and qualification of media. To operate the autoclaves, Dry heat oven, LAF Biosafety cabinets Culture handling, sub culturing, seed lot preparation and culture suspension preparation of standard microorganisms. To perform the growth promotion test. To perform the sampling and analysis (Chemical and Microbial) for Environmental monitoring Water from production area of Hormone block. To monitor the temperature recording of BOD incubators. To monitor the area temperature, relative humidity and differential pressure. To perform Bioburden test of Raw material, Finished product and In-process samples. Operation and Calibration of Total Organic Carbon analyzer and testing of water samples for TOC content. To perform the Microbial Limit test for all RM, FG and In-process samples. To prepare the trend analysis for water analysis and EMP results. To perform method validations for FG,RM and other samples in microbiology lab. Trend preparation. Review of documents in Microbiology lab. All relevant documentation of the activities.

Monitor and assess the safety of pharmaceutical products through the collection and analysis of adverse event reports. Ensure compliance with regulatory requirements related to pharmacovigilance. Prepare and submit reports to regulatory authorities regarding product safety. Collaborate with internal teams to develop risk management strategies for pharmaceutical products. Provide training and guidance to staff on pharmacovigilance practices and policies. Maintain up-to-date knowledge of industry trends and regulatory changes.

I. Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner II. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies III. Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness IV. Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement V. Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly VI. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals VII. Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements VIII. Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning IX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP X. Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements XI. Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Education Qualification B. Pharma/ M.Sc Relevant Work Experience 2 years of experience in quality assurance department Competencies/Skills Collaborate to Succeed Innovate to Excel Perform with Accountability Lead with Empathy Act with Agility Strong Domain Knowledge People Management Job Location Rangpo Shift Hours

Minimum B.E/BTech Degree or demonstratable equivalent good level experience. Compelling experience in Automation and Control Engineering discipline Thorough knowledge of engineering practices and economic principles, calculation methods, design details, international codes and standards, procedures, and specifications Track record of active Pharmaceuticals with knowledge of various legislation requirements; EUdraLes, MHRA, HPRA and HAS. Competency in the following technical standards; 21 CFR, ICH Q7, ISPE GAMP, BS EN 61511. FEED Experience, survey definition and execution, followed by optioneering for detailed design Experience of brownfield sites including turnarounds, shutdowns, and commissioning Detailed experience in project estimating, planning and management / leadership aspects of project work Preferred Siemens (SIMATIC S7, TIA Portal etc.) but up to date knowledge DCS, PLC systems (Emerson, Delta V, Rockwell) Cyber understanding with respect to control system networks Network architectures experience Knowledge of modern automation and control applications, tools, methodologies An understanding of instrumentation installations Commercially aware Strong leadership ability, communication skills, enthusiasm and diplomacy Inquisitive, well organized and have a keen eye for detail Able to operate in an integrated team environment supporting and leading others with a desire and ability to build trust and respect throughout the team The Lead Automation Engineer will provide technical and functional responsibility for Automation, control and safety system requirements and will work alongside other disciplines. Acts in Lead technical and supervisory roles in project definition, development, and execution Leads project sub - teams during system design and implementation Coordinates with project discipline and senior engineers to ensure correct implementation of the design for their engineering specialty and coordinates the work of engineers within their specialty Prepares and reviews engineering design drawings and documents and material and equipment specifications Resolves specialty related engineering issues by applying accepted principles, codes, and standards Produces Monthly Technical Progress Reports Control and management of discipline hours Programme input and updates Customer focal point, ensuring client satisfaction / requirements are addressed or met Support the bid and estimating function especially for future phases of work Supports RFQs and Requisitions for vendors Supports project evaluation (Technical KPIs) Mentoring ability for team members

This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years

Understanding of drawing , Should be able to do Zero Based costing for new product. Knowledge of die casting (GDC/LPDC/HPDC) process - Must Have Contribution analysis of running business On site actualization of running parts Comparison and Controlling of customer indexing and vendor prices. Price increase/decrease calculation for existing product in case of ECN Product parts actualization activity. Business case preparation. Hands on experience of MHR. Identification of new avenues for cost saving.

Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills

This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills

Scope of the role Scope - This role is responsible for Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability

Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability

This role is responsible for Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability

Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills

Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills

Executive, Batch Compliance Date: 10 Feb 2025 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma Job Title: Executive - Batch Compliance Department: Quality Location: Mumbai Grade - P1 Reports to: Manager - Quality Main purpose of role: To ensure batches are released in accordance with defined procedures and within appropriate timeframes to support business need. Key responsibilities (In Points): To perform accurate and timely review of various batch documents and confirm that the batch meets the relevant regulatory standards before being placed on the market To coordinate with the contract testing laboratory/ Manufacturers for timely analysis and provide support during technical troubleshooting. To liaise with the Global Supply Chain Management team in support of the assessment of batch/manufacturer information and business priorities To ensure that the relevant database is update with every batch released To report any out of specification or out of trend result and assist the deviation team during investigation. To support the business during tender applications by providing various quality related documents and accessories. To improve the overall cycle time on batch release. To assess the performance of every manufacturer and prepare a risk assessment report determining the level of detailed information required during batch release To ensure that the batch release and other associated SOPs are thoroughly followed and suggest improvement. Preparation of individual and team monthly reports. To ensure products are blocked/ unblocked as per request from GxP teams and relevant database is update with every action. To monitor low stock/ out of stock products and facilitate in quick release of these products. Other activities as may be required, at the discretion of management Requirement Essential Desirable Qualifications: Science Graduate (Chemistry/Biology/Pharmacy (or close equivalent) X Post graduate qualification in a relevant scientific discipline X Experience Competences: Hands on experience of at least 3 to 5 years on various laboratory instruments like HPLC, GC in a reputed Pharmaceutical company X Has experience of working in a virtual company environment X Candidate should have a thorough knowledge of cGMP and GLP and should have a good analysing and communication skills X Candidates having experience in MHRA or USFDA approved companies will have added preference X Knowledge Skills: Competent use of grammatically correct written and spoken English X Knowledge of MS Office (Word, Excel, Outlook, PowerPoint), Adobe Acrobat and web applications. X Knowledge of SAP, Veeva or equivalent software X Knowledge of European Regulations, Guidelines for pharmaceutical products X Knowledge of technical aspects of product manufacture including quality control and compliance X Personal Qualities: A Methodical, Hardworking individual X Specific awareness of Company s culture and objectives X Organization and time management skills X Ability to adapt to change X Proactive

Key Responsibilities Recruitment Selection: Organising the recruitment of staff, coordinating interviews, checking references. Coordinate with department to get exact requirements. Plan and schedule interviews and organize the interviews. Follow up with selected candidates to confirm their date of joining and keep the respective departments informed of the same. Induction: Plan and execute induction with the emphasis on moments of the truth for new employees. Complete joining formalities for the new members complete all documentation requirements. Organize a meet with the head of the departments to orient the new member about the various departments, people, and roles. Policy implementation Training Development: Work closely with senior management to identity, develop and implement training and development programs in line with the business objectives. Prepare Training Calendar and implement training plan. Organize and conducting behavioural + Technical training programmes, in association with the external / internal trainers. Training feedback and evaluation, maintaining training records, Achieve training man days as per the plan, Generation of necessary MIS Report. Audit Face IATF, WHO, ISO, Ukraine, MHRA, Sedex (CSR audit). Performance Management : Involved in review of employee reward strategy, and proposals for improvement of same. Prepare the performance appraisal for evaluating the employee performance. Given effect to after the appraisal, like preparing the increment letter, promotion latter. Time Office / Payroll: Timekeeping functions, namely checking Attendance marked in Attendance Registers for workmen and Staff, department wise. Calculates Manpower Shortage department wise and contractor wise, manpower sanctioned / allotted. Processing of salary Staff Trainee, Union workers, and contract workmen wages Full final. Detailed checking, verifying and certifying the Contractors monthly Wage Bills as per department wise allotment of manpower of each Plant; and handing over to Accounts as soon as possible. Maintaining various personnel records viz. Personal Files, Leave Application Balance Records, PF / ESIC / PT challan Records, Personal details etc. Develop and implement HR policies and procedures that support the companys mission and values. Oversee all aspects of talent acquisition, including recruiting, interviewing, hiring, and onboarding new employees. Developing and implementing a performance management system to monitor and improve employee performance. Manage compensation and benefits programs, including salary, bonuses, and other incentives. Manage employee relations, including conflict resolution, disciplinary actions, and employee grievances. Ensure compliance with all applicable laws and regulations, including employment laws, labour laws, and data privacy regulations. Develop and maintain positive relationships with employees and managers, providing guidance and support as needed. Monitor and report on HR metrics, including employee turnover, retention, and engagement. Provide regular reports and updates to senior management on HR strategy, operations, and performance. Promote a positive workplace culture that aligns with the companys mission and values. Stay up to date on industry trends and best practices in HR management.

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile Allergy Therapy Products, and Generics APIs, comprising Solid Dosage Formulations Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. RD works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. ",

We are seeking an experienced Head in the Quality Assurance department to oversee and ensure the highest level of quality standards across our organization. The ideal candidate will have at least 15 years of experience in quality assurance, with a proven track record of managing and leading a team. 1. Quality Management System (QMS) Oversight Develop, implement, and maintain the Quality Management System in compliance with local and international regulations (e.g., CDSCO, WHO, USFDA, MHRA). Conduct regular reviews and updates of QA policies and procedures. 2. Regulatory Compliance Ensure all manufacturing processes and documentation comply with regulatory requirements. Prepare for and manage regulatory inspections and audits. Liaise with regulatory bodies and ensure timely submission of required documentation. 3. Product Quality Assurance Oversee all aspects of quality control for OSD formulations, including raw materials, in-process controls, and finished products. Approve or reject raw materials, intermediates, and finished products based on quality standards. 4. Quality Control (QC) Coordination Collaborate closely with the QC department to ensure proper testing of materials and products. Review and approve QC reports and ensure timely release of products. 5. Deviations and Investigations Lead investigations into quality incidents, deviations, or non-conformances. Implement corrective and preventive actions (CAPA) to prevent recurrence. 6. Documentation and Record Keeping Ensure proper documentation practices (GDP) are followed. Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other critical documents. 7. Training and Development Conduct training programs for QA and plant staff on quality standards, regulations, and best practices. Foster a culture of continuous improvement and compliance. 8. Supplier and Vendor Management Approve and audit suppliers and vendors to ensure the quality of raw materials and services. Ensure supplier compliance with quality agreements and standards. 9. Risk Management Identify, assess, and mitigate risks associated with product quality. Conduct risk assessments and implement control measures as necessary. 10. Cross-functional Collaboration Work closely with production, RD, and other departments to ensure quality is integrated into all processes. Provide QA support during product development and technology transfer. 11. Continuous Improvement Drive continuous improvement initiatives to enhance product quality and operational efficiency. Monitor industry trends and update practices accordingly. 12. Ethical and Safety Compliance Ensure all QA activities are conducted ethically and with a focus on employee and consumer safety. Promote a safe working environment and adherence to health and safety regulations. This role demands strong leadership, excellent communication skills, and a deep understanding of pharmaceutical quality standards and regulatory requirements Preferred candidate profile Head- Quality Assurance in EU approved OSD Pharma Plant Perks and benefits Company Family Accommodation will be provided Personal Mediclaim and Accident Insurance upto Rs 5 lakhs