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12 Production Documentation Jobs

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12.0 - 20.0 years

10 - 18 Lacs

Dombivli

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We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production Records, and Validation Protocols across departments. Coordinate process, cleaning, and analytical method validations as per the Validation Master Plan. Prepare, review, and manage regulatory documentation including DMFs/ASMFs in CTD format (Modules 1, 2, 3). Liaise with regulatory authorities and customers for audit readiness, document submissions, and compliance queries. Oversee training programs for plant personnel and ensure continuous adherence to GMP standards. Conduct Product Quality Reviews and implement risk management tools like FMEA, HACCP, and HAZOP where applicable. General Requirements: Thorough understanding of global regulatory guidelines (ICH, WHO, USFDA, etc.). Strong analytical, documentation, and decision-making skills. Proficient in regulatory submissions and quality review documentation. Familiarity with stability studies and establishing expiry/retest periods. Hands-on experience with validation protocols and equipment calibration systems. Ability to lead cross-functional teams and ensure site-wide compliance. Excellent verbal and written communication skills. Willingness to take ownership and drive continuous improvement initiatives.

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10.0 - 16.0 years

10 - 18 Lacs

Yadagirigutta

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Role & responsibilities Manage and maintain all production-related documentation, including Batch Manufacturing Records (BMRs), SOPs, Logbooks, and Validation Protocols. Review and ensure timely preparation, issuance, and retrieval of GMP documents in accordance with cGMP and GDP requirements. Coordinate with the QA and Production teams to ensure documentation accuracy and completeness. Lead documentation readiness for audits (regulatory, customer, and internal). Support and coordinate the preparation of audit responses, CAPA documentation, and follow-up actions. Ensure timely updates and version control of SOPs and Master Manufacturing Records. Implement document control systems and ensure document security and traceability. Monitor change control, deviations, and incident documentation related to production operations. Ensure compliance with data integrity and documentation best practices. Collaborate with cross-functional teams to enhance regulatory compliance culture on the shop floor. Provide training on documentation practices, cGMP, GDP, and audit readiness to production staff. Maintain and track compliance metrics and drive continuous improvement in documentation practices. Participate in regulatory inspections and ensure the availability of relevant documentation. Preferred candidate profile In-depth understanding of cGMP, GDP, and regulatory audit requirements Experience in handling documentation for USFDA, EU, WHO, and other regulatory bodies Strong analytical and detail-oriented mindset Excellent written and verbal communication skills Proficiency in documentation systems and electronic document management (EDMS) Ability to train and mentor teams on compliance practices

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3.0 - 8.0 years

6 - 9 Lacs

Mysuru, Bengaluru

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Hi Greetings from Avani consulting , We have job opportunities with (pharma company) for the production department in mysore location NOTE :- We are going to conduct a Walk-in interview in Mysore on 21-june- 2025(Saturday) Whom ever are interested they can join for interview just share updated resume Job Description for Production-Associate Position- Associate Work Experience Min 3-12 yrs in API Drive Location : Banglore Work Location: Mysore ( Nanjangud) Gender Any Qualification- B.Tech Chemical Engineering/M Sc and Bsc Chemistry /Diploma in chemical Engg Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of the manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by the Production head. if interested please share updated resume and Fill the details to 7780363938 or Jyotsna @avaniconsulting.com 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:e 8. Relevant years of experience in on roll :

Posted 1 week ago

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2.0 - 5.0 years

2 - 4 Lacs

Ahmedabad

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Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 2-5 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.

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3.0 - 8.0 years

5 - 9 Lacs

Mysuru

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Hi Greetings from Avani consulting , We have job opportunities with (pharma company) for the production department in mysore location NOTE :- We are going to conduct a Walk-in interview in Mysore on 14-june- 2025(Saturday) Who ever are interested they can join for interview just share updated resume Job Description for Production-Associate Position- Associate Work Experience Min 3-12 yrs in API Location Mysore ( Nanjangud) Gender – Any Qualification- B.Tech Chemical Engineering/M Sc and Bsc Chemistry /Diploma in chemical Engg Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPE’s are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of the manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by the Production head. if interested please share updated resume and Fill the details to 7780363938 or Jyotsna @avaniconsulting.com 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:e 8. Relevant years of experience in on roll :

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3.0 - 8.0 years

4 - 8 Lacs

Mysuru

Work from Office

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Hi Greetings from Avani consulting , We have job opportunities with (pharma company) for the production department in mysore location NOTE :- We are going to conduct a Walk-in interview in Mysore on 14-june- 2025(Saturday) Who ever are interested they can join for interview just share updated resume Job Description for Production-Associate Position- Associate Work Experience Min 3-12 yrs in API Location – Mysore ( Nanjangud) Gender – Any Qualification- B.Tech Chemical Engineering/M Sc and Bsc Chemistry /Diploma in chemical Engg Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPE’s are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of the manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by the Production head. if interested please share updated resume and Fill the details to 7327039030 or mona@avaniconsulting.com 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:e 8. Relevant years of experience in on roll :

Posted 1 week ago

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4.0 - 8.0 years

3 - 4 Lacs

Faridabad

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Roles and Responsibilities Oversee production activities to ensure timely completion of tasks and meet quality standards. Manage manpower effectively, allocating resources efficiently to achieve productivity goals. Ensure accurate documentation of production processes, including process settings and documentation. Monitor machine performance, identifying areas for improvement and implementing changes as needed. Coordinate with other departments to resolve issues related to material availability, tooling, or equipment maintenance.

Posted 3 weeks ago

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1.0 - 6.0 years

3 - 8 Lacs

Satara

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NUTRIS CROP SOLUTIONS INDIA PVT.LTD is looking for EXECUTIVE - PRODUCTION to join our dynamic team and embark on a rewarding career journey. Production Planning: Developing production plans, schedules, and strategies to meet output goals and deadlines. Operations Management: Overseeing day-to-day manufacturing activities, ensuring adherence to production schedules, and resolving operational issues. Resource Allocation: Managing resources including manpower, equipment, and materials to optimize production efficiency. Quality Assurance: Implementing quality control measures, monitoring production standards, and ensuring product quality meets specified criteria. Process Optimization: Identifying areas for improvement in production processes and implementing measures to enhance efficiency and reduce costs. Health and Safety: Ensuring compliance with health and safety regulations, maintaining a safe work environment, and minimizing workplace incidents. Team Leadership: Leading and supervising production teams, providing guidance, training, and support to ensure productivity and morale. Skills and Qualifications: Production Management: Strong understanding of production processes, manufacturing principles, and operations management. Leadership Skills: Ability to lead teams, make decisions, and effectively manage resources. Problem-Solving: Capacity to identify issues, troubleshoot problems, and implement solutions in a production environment. Analytical Thinking: Proficiency in analyzing production data, identifying trends, and making data-driven decisions.

Posted 4 weeks ago

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3.0 - 8.0 years

2 - 4 Lacs

Hyderabad

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Embark on a Global Growth Journey: Production Chemist Location: Hyderabad, India Company: Lactonova No of Positions : 3 Industry: Nutraceuticals & Pharmaceutical Formulations If youre ready to revolutionize the Nutraceuticals and Pharmaceutical Formulations space, this is your opportunity to lead and grow with us as a Production Chemist Job description Developing and optimizing production processes for pharmaceutical formulation based on client requirements Conducting experiments and trials to determine the best production process for chemicals Creating and maintaining detailed records of the production process, including batch records, protocols, and reports Monitoring production processes to ensure they meet quality standards and product specifications Troubleshooting and resolving issues related to the production process Maintaining equipment used in the production process and coordinating maintenance activities with the maintenance team Conducting safety audits and maintaining a safe working environment Identifying opportunities for process improvements and implementing changes to increase efficiency and productivity Providing technical support to production teams and resolving production-related issues Strong analytical and problem-solving skills Excellent communication and interpersonal skills What Sets You Apart: Experience: Minimum 3 years in Production Chemist within Pharmaceutical Formulations or Nutraceutical industries. Qualification Bsc Chemistry, Msc Chemistry Language Proficiency: Fluent in English and Hindi (Additional languages are a bonus). Why This Opportunity is Special: Global Impact: Join a forward-thinking, globally recognized leader in the Nutraceutical and Pharmaceutical Formulations space. Collaborative Culture: Work in an entrepreneurial environment that values innovation and results. Unlimited Growth Potential: Be a key player in shaping the future of wellness and redefine industry standards. How to Join Us: Ready to Lead and Inspire? Take the leap and send your CV and cover letter to [ hra@lactonova.com , +91 6303037351]. Lets grow together, make an impact, and lead the future of wellness in Nutraceuticals and Pharmaceutical Formulations.

Posted 4 weeks ago

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0.0 years

0 Lacs

Ahmedabad, Gujarat, India

On-site

Foundit logo

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission. Production QMS Outline: Production Documentation Key Responsibilities: . Handling of Production change control activities and cross functional change impact assessment. . Handling of Production document change request and cross functional DCR impact assessment. . Execution of CA/PA records and perform effectiveness check of implemented actions. . Perform risk assessment for Production QMS elements as per impact assessment. . NCR/SNCR, Market complaint and Laboratory investigation and prepare report. . Production documentation related to QMS elements, SOP, Audit compliance. . Regulatory observation compliance. . Work for Audit readiness. . Execution of other project assigned time to time. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Posted 1 month ago

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0.0 - 5.0 years

0 - 3 Lacs

Hyderabad

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Role & responsibilities production chemist Preferred candidate profile pharma experience, API, BULK DRUG,GMP, GLR,SSR,CENTRIFUSE,BPR,

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1.0 - 3.0 years

2 - 4 Lacs

Ahmedabad

Work from Office

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Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 1 -2 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.

Posted 1 month ago

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