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4.0 - 8.0 years
5 - 9 Lacs
Dholka
Work from Office
Role : Senior Executive Qualification: M. Pharma/B. Pharma Experience : 4 to 8 Years Location : Dholka, Gujarat Responsibilities 1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline. 6. Preparation of COPPs (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals. 7. Preparation of Tender documents. 8. Support for activities of contract manufacturing product Preferred candidate profile Must have experience in Pharmaceuticals Industries
Posted 4 days ago
3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for line clearance activities before commencing operations, following the preventive maintenance schedule of machines, cleaning and sanitizing the visual inspection and packing area, operating the machines, and filling the log of the general area according to SOP and work execution. Additionally, you must adhere to cGMP, GDP, and maintain discipline in the department, ensuring all employees follow the same standards. Your duties will also include ensuring that all equipment and lines are in a validated and calibrated status, preparing daily production reports, and creating production planning on a monthly and daily basis based on requirements and material availability. You will handle tasks such as change control, deviations, CAPA, investigations, as well as document management including BMRs, BPRs, and master SOPs. Moreover, you will be responsible for preparing and reviewing protocols and reports as needed, overseeing the preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. Line clearance activities before commencing operations like manufacturing, sterilization, and filling are also part of your responsibilities, as well as checking records and logbooks related to various manufacturing processes. In addition to your defined job responsibilities, you may be required to perform other activities as instructed by the Head of Department (HOD) and provide training to subordinates, technicians, and operators. You must attend training sessions as per the schedule and ensure training aligns with the Training Needs Identification (TNI) process. Key Skills required for this role include adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO), accurately completing BMRs/BPRs, understanding deviations, change control, and CAPA, as well as the ability to inspire and guide others towards common goals while fostering a positive team environment. Qualifications: M.Sc. / B. Pharm / M.Pharm.,
Posted 1 week ago
10.0 - 19.0 years
8 - 18 Lacs
Mumbai, Thane, Navi Mumbai
Work from Office
Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution. Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines. Demonstrates knowledge of key processes, procedures and tools. Regulatory Skills: Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry. Leadership Skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format. Ability to comprehend and summarize complex technical data. Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.
Posted 1 week ago
6.0 - 11.0 years
4 - 9 Lacs
Bharuch, Ahmedabad, Vadodara
Work from Office
Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y
Posted 1 week ago
12.0 - 15.0 years
15 - 20 Lacs
Palghar
Work from Office
Job Location Wada, Palghar Age Below 50yrs Role & responsibilities : Operate the organization as per plan & profitable through strategy planning and execution of a Tablet Capsules Ointment & Liquid section. To meet the manufacturing target within the norms and budget. To motivate all functional department to achieve management goal. To ensure all functional heads are executing their responsibilities are effectively. Review weekly, monthly, quarterly and year planning and budgeting. Operate the plant as per regulatory and Government norms. Handling of production documents and review. Preliminary and first hand knowledge and handling all types of equipment which are used in Tablet/ Capsules/ Ointment/ Liquid manufacturing. Process trouble shooting, new product batches monitoring, RM + PM Planning. Maintaining and updating batch production record online Keeping all documents as required by cGMP, WHO GMP, GLP norms. Handle all production activities including co-ordination with QA / QC / RA / FDA / Store & Maintenance Department. Execution & Monitoring of process validation & Cleaning Validation Batches. Ensuring that all products are manufactured and stored as per WHO-GMP norms. Ensuring product quality is maintained. Others as added and or required in the course & duty.
Posted 1 week ago
5.0 - 8.0 years
7 - 10 Lacs
Bengaluru, Ramanagara
Work from Office
Role & responsibilities Shall be take care of process Equipments ( preventive Maintenance , Breakdown , QMS ) Preferred candidate profile Candiate should have very deep knowledge about preventive maintenance and breakdown activities pertaining process equipments. Also shold velwersed with QMS GMP activities.
Posted 1 week ago
15.0 - 20.0 years
20 - 25 Lacs
Pune
Work from Office
Position: Site Head (Sr. Manager) - Production Location: Ranjangaon, Near Pune Reporting To: Head - Manufacturing Operations Industry: Pharmaceutical Manufacturing Experience: 15+ years in Plant leadership roles, preferably in pharmaceutical or manufacturing industries About Fresenius Kabi At Fresenius Kabi, we are driven by a commitment to improve the quality of lives: We are Committed to life. We strive for continuous innovation with our outstanding manufacturing capabilities, unique channel access, and customer proximity. With our four complementary business areas BioPharma, Pharma (primarily IV drugs and infusion therapy), Medical Nutrition, and MedTech; Fresenius Kabi plays a vital role in the treatment of chronically and critically ill patients across various healthcare settings. For instance, over 70% of our IV drug units shipped in the US are on the Essential Medicines List of the US Food and Drug Administration, emphasizing the importance and impact of our products. All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations. For us, care is a fundamental obligation, mission, and daily source of inspiration. It is the momentum that pushes us forward to help elevate the quality of life for both caregivers and those who need it most: critically and chronically ill patients. By providing essential medicines and technologies for infusion, transfusion, and medical nutrition, we are helping advance the future of healthcare, making it even more accessible, reliable, and in tune with current and future needs. Our principles: The Fresenius Principles form the basis of our company culture, with which we support our #FutureFresenius strategy. They describe what we stand for and how we operate, collaborate, approach challenges and make decisions as individual Fresenius employees and as a whole team. Role & responsibilities Confirm that production is carried out by appropriately qualified, experienced, and trained personnel. Ensure GMP-compliant operations across all manufacturing activities. Verify that manufacturing operations are clearly defined, systematically reviewed, and proven capable of consistently producing products of the required quality. Ensure manufacturing processes are properly validated. Provide assurance that critical process parameters are identified, controlled, and any changes are validated. Implement change control, event handling, and CAPA/action management processes in accordance with global Quality Management (QM) documents, monitor and trend accordingly. Maintain accurate records for equipment usage, calibration, maintenance, and repair including dates and responsible personnel. Oversee manufacturing equipment qualification, validation, and calibration programs. Ensure proper storage and handling of materials and products covering receipt, quarantine, sampling, storage, labeling, dispensing, processing, and packaging according to written procedures. Execute yield checks and quantity reconciliations to confirm no discrepancies exceed acceptable limits. Conduct in-process and environmental controls as required, ensuring accurate recording. Contribute to investigations of product quality defects. Control reprocessing or reworking of materials to prevent unauthorized use. Prevent cross-contamination and mix-ups during manufacturing, packaging, and labeling operations. Implement and monitor progress toward EHS policy objectives. Create, manage, and update documentation related to the Environmental Health & Management System. Maintain surveillance of compliance with legal and organizational requirements. Report EEHS performance metrics to top management. Conduct regular reviews of occupational risks and environmental aspects. Provide training and awareness to employees to minimize accidents and environmental impact. Liaise with corporate and global EEHS representatives regarding relevant issues. Conduct audits of the Environmental, Energy, and Health & Safety Management System Ensure realistic commitment to the production plan based on machine utilization and manpower availability. Collaborate with the Site Head to escalate and resolve key events affecting production, quality, and safety. Review and propose capital expenditure (CAPEX) and operational expenditure (OPEX) budgets. Lead and drive continuous improvement projects by identifying suitable opportunities and overseeing their implementation. Provide ongoing coaching and support to team members to build capability and strengthen performance. Proactively mitigate potential conflicts between internal and external stakeholders.
Posted 1 week ago
4.0 - 7.0 years
4 - 7 Lacs
Kolkata
Work from Office
JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.
Posted 2 weeks ago
6.0 - 10.0 years
5 - 6 Lacs
Sangareddy
Work from Office
Safety roles within pharmaceutical or chemical industries; experience in a pellets manufacturing setup is preferred. OSHA, WHO-GMP, NDMA guidelines, Risk Assessment tools (HAZOP, JSA), ETP operations Proficiency in MS Office, Safety Audit Tools. Required Candidate profile Conduct risk assessments (HIRA, JSA) control dust generation and potential explosion risks occupational health, process safety, fire prevention, and statutory compliance Flexible with the shifts .
Posted 2 weeks ago
10.0 - 15.0 years
6 - 6 Lacs
Sangareddy
Work from Office
WHO-GMP guidelines, pharmaceutical material handling, inventory systems (ERP/SAP) Material handling, storage, and movement comply with WHO-GMP Strong expertise in pharmaceutical warehousing, inventory control, regulatory compliance, cross-functional. Required Candidate profile Lead day-to-day warehouse operations receipt, storage, issuance, and dispatch of raw materials, packaging materials, intermediates, finished goods. Relevant experience in a pharmaceutical warehouse
Posted 2 weeks ago
7.0 - 11.0 years
8 - 10 Lacs
Bengaluru
Work from Office
Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports.
Posted 2 weeks ago
1.0 - 3.0 years
1 - 1 Lacs
Nagpur
Work from Office
1. Microbial Testing MLT and Pathogens 2. Environmental Monitoring- Clean room viable and non-viable particle counts 3. Water Testing - specific pathogens. 4. Documentation and reporting as per GDP
Posted 2 weeks ago
8.0 - 10.0 years
8 - 10 Lacs
Udaipur, Bengaluru
Work from Office
Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems
Posted 2 weeks ago
3.0 - 7.0 years
3 - 6 Lacs
Udaipur, Bangalore Rural
Work from Office
Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA
Posted 2 weeks ago
3.0 - 4.0 years
5 - 6 Lacs
Hyderabad
Work from Office
Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to
Posted 3 weeks ago
4.0 - 8.0 years
3 - 7 Lacs
Noida
Work from Office
We are looking for a skilled Regulatory Engineer with 4 to 8 years of experience to join our team at Apptad Technologies Pvt Ltd. The ideal candidate will have a strong background in regulatory affairs and excellent analytical skills. Roles and Responsibility Develop and implement regulatory strategies to ensure compliance with industry standards. Collaborate with cross-functional teams to identify and mitigate regulatory risks. Conduct thorough analysis of regulatory requirements and develop effective solutions. Prepare and submit regulatory documents to relevant authorities. Monitor and report on regulatory changes that may impact the company. Provide training and guidance to internal stakeholders on regulatory matters. Job Strong knowledge of regulatory affairs and industry standards. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Effective communication and interpersonal skills. Strong attention to detail and organizational skills. Familiarity with regulatory software and systems. Experience working in an employment firm or recruitment services firm is preferred. For more information, please contact us at 6566508.
Posted 4 weeks ago
3.0 - 8.0 years
3 - 4 Lacs
Pune
Work from Office
B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
8.0 - 13.0 years
6 - 9 Lacs
Pune
Work from Office
B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
4.0 - 9.0 years
4 - 6 Lacs
Pune
Work from Office
Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
3.0 - 8.0 years
3 - 4 Lacs
Mumbai
Work from Office
B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
8.0 - 13.0 years
6 - 9 Lacs
Mumbai
Work from Office
B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
4.0 - 9.0 years
4 - 6 Lacs
Mumbai
Work from Office
Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
3.0 - 8.0 years
3 - 4 Lacs
Bengaluru
Work from Office
B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
8.0 - 13.0 years
6 - 9 Lacs
Bengaluru
Work from Office
B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
4.0 - 9.0 years
4 - 6 Lacs
Bengaluru
Work from Office
Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience
Posted 1 month ago
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