143 Who Jobs

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

Responsible for formulation development for OSD, external preparations, oral liquids, and injectables. Responsible for pre-formulation studies, prototype development, and scale-up activities. Ensure compliance with regulatory guidelines (ICH, WHO, USFDA, etc.). Collaborate with cross-functional teams (A, C, RA, Production) for tech transfer. Mentor junior scientists and manage project timelines and documentation.

Hands-on experience in monitoring manufacturing and packaging processes, line clearance, and in-process checks. Proficiency in DOC-MS systems, SOP preparation, deviation handling, and change control. Involvement in TT activities including protocol review, execution, and coordination between RCD and manufacturing. Familiarity with validated software systems that meet FDA electronic records and signatures requirements. Strong understanding of equipment qualification (D, I, O, P), process validation, and cleaning validation. E-BMR G E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability. uality Management Systems (MS): Implementation and maintenance of MS aligned with regulatory standards . Risk Assessment: Ability to conduct and document risk assessments for processes, equipment, and product quality.

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master Formula Records (MFR), Manufacturing Process Records (MPR), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR) . Review and analyze the Annual Product Quality Review (APQR) to assess product performance and compliance. Prepare and review Standard Operating Procedures (SOPs) to ensure alignment with regulatory guidelines and internal standards. Review Stability Study Protocols and Reports to support product shelf-life determination. Oversee the preparation, review, and execution of Qualification and Validation activities for equipment, systems, and processes. Review and monitor the Training Plan to ensure effective implementation and documentation of employee training. Review and maintain Document Control Procedures to uphold quality and compliance standards. Maintain confidentiality of financial data and ensure accuracy and integrity in reporting.

Job Title: Site Manager / Assistant Site Manager No. of Positions: Site Manager - 1 | Assistant Site Manager - 1 Company Name: The South Indian Manufacturing Company Company Website: www.saibol.com Location: Madurai (Local candidates preferred or must be willing to relocate) About the Company The South Indian Manufacturing Company is a reputed pharmaceutical manufacturer committed to excellence in quality, compliance, and operations under strict GMP/ISO standards. Qualifications Graduate / Postgraduate (Science, Engineering, or Management preferred) Experience 7 - 10 years in factory/site operations management Preference for candidates with WHO GMP pharma management experience Candidates from ISO 9001-certified firms with 50+ employees may also apply Key Responsibilities Manage day-to-day site operations and workflow efficiency Ensure systems are compliant with GMP / ISO standards Implement cost control measures and reduce wastage Supervise and guide staff, ensuring SOP adherence Represent management during audits and inspections Drive operational excellence and ensure compliance at all times Desired Candidate Profile Strong background in WHO GMP pharmaceutical manufacturing (preferred) or ISO 9001-certified industries Proven leadership, people management, and decision-making skills Ability to enforce compliance and optimize costs Strong organizational and communication skills Key Skills Factory Management | WHO GMP | ISO 9001 | Cost Control | People Management | Operations Compensation Site Manager: 35,000 - 55,000 per month Assistant Site Manager: 25,000 - 40,000 per month

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Operate and maintain WTP RO UV and softener systems Ensure purified and process water as per pharma standards Perform routine maintenance of pumps valves filters membranes Monitor pH TDS conductivity hardness and microbial load Required Candidate profile Diploma BE in Mechanical Electrical Chemical 2 to 5 yrs exp in WTP RO Softener Pharma Utilities Knowledge of cGMP WHO norms Maintain logs and support GMP WHO

M.Pharma/Phd - Phytochemistry, pharmacognosy, Nataral Products Chemistry 5 - 7 Years 8 - 10 LPA Location - Thane West Phytochemical Expertise product Development Extraction System Design Quality Control prepare Regulatory Documents

Key Responsibilities Lead and manage the Quality Assurance department, ensuring compliance with GMP norms and regulatory requirements of WHO, EU GMP, PICS, TGA, MHRA, USFDA, and other global agencies . Develop, implement, and monitor Quality Management Systems (QMS) across all QA functions. Ensure strict adherence to SOPs and continuous improvement practices in line with regulatory expectations. Oversee handling of rejected materials, market complaints, product recalls, deviations, change controls, CAPA, and CCF . Manage end-to-end Validation and Qualification activities (process validation, cleaning validation, equipment qualification, analytical method validation, etc.). Ensure audit readiness at all times and lead regulatory/customer audits and inspections. Review, approve, and monitor the control of documents, records, and quality risk management systems . Provide leadership and guidance to QA teams, including training, mentoring, and performance monitoring. Collaborate with cross-functional teams (Production, QC, R&D, Regulatory Affairs) to maintain high-quality standards. Drive initiatives for continuous quality improvement and compliance to ensure products meet global regulatory expectations. Desired Candidate Profile B.Pharm / M.Pharm with 1520 years of proven experience in Quality Assurance of Pharma Formulation Units . Strong command over WHO GMP, EU GMP, PICS, TGA, MHRA, and USFDA regulatory guidelines . Expertise in handling market complaints, investigations, and product recalls . Thorough knowledge of CAPA, deviations, and change control processes . In-depth experience in validation & qualification activities . Excellent leadership, decision-making, and cross-functional coordination skills. Strong communication skills with the ability to face regulatory and customer audits confidently. Willingness to relocate to Gandhidham . Candidates who can join immediately will be given preference. Compensation & Benefits Competitive salary aligned with industry standards. Relocation support for suitable candidates. Opportunity to head the QA function and drive strategic quality initiatives for a regulated market facility. Role & responsibilities

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficiency responses and/or post-approval submissions for above markets. Worked on various dosage forms including complex generics. Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections. Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections. Hands on experiance for ECTD compilation. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Masters Graduation in Pharmacy or Science

Equipment & Utility Maintenance Troubleshooting & Repairs Compliance & Documentation Continuous Improvement Safety & Housekeeping To carry out installation, operation, maintenance, and troubleshooting of electrical systems, equipment, and utilities. Required Candidate profile Knowledge of electrical circuits, PLCs, VFDs, control systems, and instrumentation. Understanding of GMP, WHO, USFDA, MHRA requirements. Hands-on experience in troubleshooting electrical automation .

Lead formulation R&D for OSD, external, and liquid preparations. Oversee pre-formulation, development, and scale-up, ensuring regulatory compliance. Manage tech transfer and mentor junior scientists. Required Candidate profile B.Pharm/ M.Pharm 6-10 Yrs

Lead formulation R&D for OSD, external, and liquid preparations. Oversee pre-formulation, development, and scale-up, ensuring regulatory compliance. Manage tech transfer and mentor junior scientists. Required Candidate profile B.Pharm/ M.Pharm 6-10 Yrs

Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority

Applications are invited for the Project Associate-I for the MoES funded project under Deep Ocean Mission scheme in the School of Computer Science and Engineering (SCOPE), at Vellore Institute of Technology (VIT), (MoES/PAMC/DOM/58/2023 (E-14510) Title of the Project : Design and Development of Machine Learning Models and Expert System for Automated Characterization of Underwater Species: Indian Scenario Qualification : BE/B.Tech(CSE/IT/ECE/EEE) Describe if any : Candidates who have knowledge in programming, app development, image processing, full stack development, machine learning, deep learning and computer related field will be given preference Stipend : Rs. 31,000/- per month + HRA (as per norms) for applicants with CSIR –UGC NET including lectureship (Assistant Professorship) or GATE Rs. 25000/- per month + HRA (as per norms) for applicants who do not fall under (i) above Sponsoring Agency : Ministry of Earth sciences, Government of India, New Delhi . Duration : 24 Months Principal Investigator : Dr. Swathi J N, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Co-Principal Investigator : Dr. Boominathan P, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Dr. Shashank Mouli Satapathy, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Send your resume along with relevant documents pertaining to the details of qualifications, scientific accomplishments, experience (if any) and latest passport size photo etc. on or before (12 /9/2025) through online http://careers.vit.ac.in No TA and DA will be paid for appearing the interview. Shortlisted candidates will be called for an interview at a later date which will be intimated by email. The selected candidate will be expected to join at the earliest.

Position- Executive/Sr. Executive Dept.-Regulatory Affairs Key Responsibilities Act as the first point of support for Business Development Managers on product-related queries from India. Coordinate and organize audits of supplier production facilities to ensure compliance with international standards. Gain exposure to and support during international regulatory audits (USFDA, WHO, ANVISA, EDQM). Understand and translate client quality parameters for raw materials, ensuring supplier adherence. Monitor supplier manufacturing processes for compliance with national and global standards. Assist in preparing and managing documentation for specification setting, change controls, regulatory submissions, annual product reviews, and investigations with suppliers. Maintain up-to-date knowledge of regulatory requirements across different zones and international guidelines. Support clients during factory audits and commercial visits to supplier facilities. Collaborate with cross-functional teams to aid organizational growth and business development. Ensure timely completion of regulatory submissions and strict adherence to quality standards. Represent the organization at national and international exhibitions. Participate in continuous training programs to upgrade skills and regulatory knowledge. Qualifications & Skills Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field. 25 years of experience in Regulatory Affairs, Quality Assurance, or Compliance (pharmaceutical/chemical industry preferred). Strong understanding of international regulatory guidelines (USFDA, WHO, ANVISA, EDQM). Experience in supplier audits and compliance monitoring. Excellent communication, coordination, and stakeholder management skills. Strong attention to detail and ability to work under strict timelines. Willingness to travel for audits, client visits, and international exhibitions.

We're Hiring: Team Leader Clinical Data Operations Location: Hyderabad, India (Onsite) Industry: BPO / Healthcare / Life Sciences Apply: rani.ramchandani@sagilityhealth.com Join our dynamic team at Sagility as a Team Leader overseeing U.S. healthcare and pharmaceutical data management projects. If you have 5 to 6 years of experience , including 2+ years in a leadership role, and a strong background in clinical data, terminology mapping, Data Harmonization and MedDRA Dictionary. Leadership in clinical data ops Hands-on with ICD, LOINC, SNOMED, RxNorm, etc. Strong client communication skills US healthcare & pharma knowledge essential Are you flexible with night shift and afternoon shifts. Looking for Candidates with D Pharma graduation only Send your CV to: rani.ramchandani@sagilityhealth.com Lets build something impactful together!

Responsible for nutrition addition, harvesting, washing, homogenization, spray drying, packing. Shall check the maintenance of the department, premises, and equipment as per SOP and GMP norms.

The ideal candidate brings 1-7 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Lead microbiology practices including EM, MLT, sterility assurance, water/air monitoring, microbial ID/trending, and method validation; establish contamination control strategy and support media fills and aseptic behaviors Manage QC lab workflows: RM/PM/FG testing, HPLC/GC operations, stability studies, instrument calibration/qualification (IQ/OQ/PQ), and review of analytical reports and CoAs Additional info: Education: B.Sc./M.Sc. in Microbiology/Biotech with sterile USFDA experience Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Additional info: Key Skills: GMP Documentation, Batch Execution, Troubleshooting, R&D Tech Transfer, Process Optimization Experience: 5 to 10 years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

Sterile Manufacturing based in Waghodia, Vadodara. The ideal candidate brings 1- 7 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Additional info: Role: Machine Operators & Production Officers Education: ITI/Diploma for Operators; B.Pharm/M.Pharm for Officers Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Additional info: Key Skills: IPQA, Vendor Qualification, Analytical QA Qualification: M.Pharm / B.Pharm / M.Sc Experience: 5 to 8 years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

Executive for Micro R&D 1 Post based in Amritsar. The ideal candidate brings 6 - 8 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Lead microbiology practices including EM, MLT, sterility assurance, water/air monitoring, microbial ID/trending, and method validation; establish contamination control strategy and support media fills and aseptic behaviors. Support R&D/formulations: experiment planning, DoE, scale-up/tech transfer, method/cleaning validation, and dossier documentation aligned to global registration needs. Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

Chief Manager Township Administration (MP 25/13) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive training and competency mapping, monitor KPIs, and uphold EHS norms across the site while partnering with leadership on policy and governance. Additional info: Qualification: B.E. / B.Tech (Civil) with First Class Age: ~45 Years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.