196 Gmp Compliance Jobs - Page 8

We are seeking a Fresher Pharmaceutical Production Executive to join our pharmaceutical production team. In this role, you will assist in the manufacturing process of pharmaceutical products, ensuring that all production activities comply with safety, quality, and regulatory standards. This is an excellent opportunity for someone looking to start their career in pharmaceutical production and contribute to the production of high-quality medicines Oversee production processes, ensure GMP compliance, and maintain batch records.

We are seeking a Fresher Pharmaceutical Production Executive to join our pharmaceutical production team. In this role, you will assist in the manufacturing process of pharmaceutical products, ensuring that all production activities comply with safety, quality, and regulatory standards. This is an excellent opportunity for someone looking to start their career in pharmaceutical production and contribute to the production of high-quality medicines Oversee production processes, ensure GMP compliance, and maintain batch records.

Role: Officer / Executive - Quality Control Job Location: Nashik At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role Purpose Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP. Role & responsibilities Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure. To maintain documents as per GLP requirements. To ensure the calibration status of laboratory equipment & instruments. To report and involve in incidence/Deviation/OOS/OOT investigations. Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements. To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications. Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise. To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable. To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 2 to 6 years experience in a reputed pharma industry. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of employee performance on the job. > Coordinating with other departments to ensure that production runs smoothly Ensuring that all safety regulations are followed in the production area. Managing all aspects of production, including hiring workers, ordering supplies, maintaining production schedules, and overseeing equipment maintenance. Reviewing production schedules and work orders to ensure that production goals are being met in handling QMS activities. for more details please reach out Venkat -9381915043 or please share your CV to venkateswara.k@talent21.in

Roles and Responsibilities Monitor machine performance and troubleshoot issues to minimize downtime and optimize productivity. Perform routine maintenance tasks on injection molding machines and GDP equipment to ensure optimal condition. Ensure compliance with Good Manufacturing Practices (GMP) guidelines during production processes. Collaborate with team members to achieve daily goals and meet quality standards.

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating procedures (SOPs), work instructions, and quality records. Prepare detailed reports on quality performance, including non-conformance incidents and corrective actions taken. Process Improvement: Analyze production workflows and recommend improvements to enhance efficiency and quality. Participate in root cause analysis for production issues and implement preventive measures. Key Skills and Competencies: In-depth knowledge of Quality Management Systems and standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Proficiency in using quality management tools and techniques. Familiarity with relevant USFD, EU, TGA regulatory requirements and industry best practices.

JD. * Lead IT strategy & operations: infrastructure, servers, Oracle ERP/NetSuite. * Ensure GMP pro custamization,compliance: systems, audits, security, cybersecurity. * Manage LIMS installation, SER, PRODUCT serialization: GMP adherence. Office cab/shuttle Health insurance Provident fund Annual bonus

Job Responsibilities: Training & Development related activities in various plants (Ahmedabad based) To plan, schedule and conduct technical training program for new recruits / existing employees by self / internal or external faculty. To work with HODs of respective units to perform training need analysis and make the training plan accordingly. To prepare GMP / technical training modules. To review and conduct the basic GMP training for contract workers and staff. To work with the department training coordinators and HODs of respective units to support in designing and development of training modules / presentation, assessments and documentation and to ensure that the employees are receive suitable training, assessment, retraining and reassessment. To visit shop floor to verify the GMP compliances as well as to support training in shop floor. To perform periodical review on the effectiveness of training programs. To monitor and support users in using QEdge TMS software and ensure compliance of training software. To perform the activities as a Plant Training Co-coordinator role in QEdge TMS software. To ensure that the training records are made available during review. for API : To plan, schedule and conduct technical training program for new recruits / existing employees by self / internal or external faculty. To work with HODs of respective units to perform training need analysis and make the training plan accordingly. To prepare training SOP (s), yearly training plan and schedule and GMP / technical training modules. To review and conduct the basic GMP training for contract workers. To work with the department training coordinators and HODs of respective units to support in designing and development of training modules / presentation, assessments and documentation and to ensure that the employees are receive suitable training, assessment, retraining and reassessment. To visit shop floor to verify the GMP compliances as well as to support training in shop floor. To perform periodical review on the effectiveness of training programs. To monitor and support users in using QEdge TMS software and ensure compliance of training software. To perform the activities as a Plant Training Co-coordinator role in QEdge TMS software. To ensure that the training records are made available during review. To initiate Change control, Deviation, CAPA and other QMS activities as per the need. Interested candidates are can apply on Darpana: 9978604075 OR can email me on darpana@upman.in

Alkem MedTech Pvt Ltd is a wholly owned subsidiary of Alkem Laboratories Ltd, which is the 5th largest listed Pharmaceutical company in terms of market share. As the first MedTech venture of Alkem Labs, Alkem MedTech is dedicated to advancing precision, high-risk, and implantable medical devices along with their accessories. MedTech is a strategic priority for Alkem Labs, representing a significant growth avenue. We are beginning our MedTech journey by focusing on Musculoskeletal solutions and have plans to expand into multiple segments, establishing a robust, multi-faceted MedTech company in the near future. Alkem MedTech will be manufacturing in India, aligning with the vision of the Government of India to boost domestic production and innovation in the medical technology sector. We are looking for passionate and innovative talents to join our pioneering team. If you are excited about shaping the future of medical technology and want to be part of a transformative journey, Alkem MedTech is the place for you. Why Join Us? Innovation-Driven Environment : Work on cutting-edge technologies in precision and implantable medical devices. Growth Opportunities : Be part of a strategic growth initiative for one of the leading pharmaceutical companies and be part of creating a legacy. Collaborative Culture : Engage with a team of dedicated professionals committed to making a difference in healthcare. Impactful Work : Contribute to life-changing medical solutions in the Musculoskeletal segment and beyond. Manufacturing in India : Support the vision of the Government of India by contributing to domestic production and innovation in the MedTech sector. Join us at Alkem MedTech and help shape the future of healthcare technology. Purpose of the role: The Microbiologist is responsible for ensuring the sterility of orthopedic knee and hip joint implants, monitoring microbiological processes, conducting microbiological testing, and ensuring compliance with relevant standards and regulations. This role involves conducting environmental monitoring, sterilization validation, and contamination control to ensure product safety and quality. Perform microbiological testing of raw materials, in-process samples, finished products, and environmental samples in accordance with GMP (Good Manufacturing Practices) and ISO standards. Conduct sterility testing, endotoxin testing, and bioburden testing of implants and related materials. Monitor and maintain environmental controls in cleanrooms, including air, surface, and personnel monitoring. Validate sterilization processes (e.g., Ethylene Oxide, Gamma Radiation) and perform routine sterilization cycle monitoring. Investigate microbial contamination events and implement corrective and preventive actions (CAPA). Maintain microbiological laboratory instruments, ensuring calibration, validation, and proper maintenance. Prepare detailed reports on microbiological findings, test results, and environmental monitoring data. Ensure compliance with regulatory requirements including FDA, ISO 13485, and EU MDR. Provide microbiological support during audits and inspections by regulatory bodies. Develop and review microbiological standard operating procedures (SOPs) and test protocols. Train and mentor junior staff on microbiological procedures and aseptic techniques.

To follow the GMP, Safety norms and adhere to Company’s Policy. Preparation for production according to written procedures,Making sure that all necessary calibrations are performed and recorded, Execution of batches as per the approved batch records

Position: Manager - Production Location: Malur Company: Khanal Foods Pvt. Ltd. Key Responsibilities: Oversee production and ensure output targets are met on time. Maintain complete facility operations and team management. Daily coordination and prioritization of team activities to meet standards in: Food Safety Quality Line Improvement Projects (LIPs) Waste Management Cost Control Submit daily production reports to management, including: Production updates Raw materials availability Finished goods Packing activity Implement and maintain 5S/Lean operations as per standards. Maintain accurate records of all production-related activities. Ensure traceability systems are in place from raw material to finished goods. Supervise cleaning and maintenance of production floor machinery. Plan and manage raw and packing materials; maintain minimum stock as per Sales Orders (SOs). Prepare and maintain documentation for ISO, HACCP, GMP, SOPs, and registers. Be flexible with work shifts and capable of handling manpower effectively. Update daily production in SAP using Bill of Materials (BOM) to ensure inventory accuracy. Conduct on-the-job training for floor staff regarding food safety standards Minimum Qualifications: Education: B.Tech / B.E in Food Technology, Dairy, or Food Processing Engineering or M.Sc. in Food Science Experience: Minimum 5 years in Food or Dairy Processing Industry Skills Required: Production Operations SOP Preparation CCP Monitoring & Record Keeping FSMS & Internal Food Safety Auditing GMP & GHP Compliance

We are seeking an experienced Production Manager to oversee and manage all plant operations, ensuring manufacturing efficiency, quality compliance, and timely delivery of products. The role involves supervising production teams, optimizing processes, ensuring adherence to safety and GMP standards, and coordinating with quality, maintenance, and supply chain departments. The ideal candidate should have strong leadership skills, hands-on plant management experience, and a proven track record in achieving production targets.

We are seeking an experienced Production Manager to oversee and manage all plant operations, ensuring manufacturing efficiency, quality compliance, and timely delivery of products. The role involves supervising production teams, optimizing processes, ensuring adherence to safety and GMP standards, and coordinating with quality, maintenance, and supply chain departments. The ideal candidate should have strong leadership skills, hands-on plant management experience, and a proven track record in achieving production targets.

We are looking for skilled committed Production Operators.candidate will be responsible for operating production machinery,maintaining production line efficiency,ensuring quality compliance cGMP environment. share resume to hrd@stedmanpharma.com

Key Responsibilities 1. Electrical Maintenance & Troubleshooting Perform preventive, predictive, and breakdown maintenance for electrical systems, MCC panels, VFDs, motors, lighting, UPS, and generators. Diagnose electrical faults and restore equipment operation with minimal downtime. Maintain and repair control circuits, distribution boards, and wiring systems. 2. Utilities & Plant Equipment Maintain electrical systems for utilities like boilers, chillers, cooling towers, water treatment plants, and HVAC systems. Monitor and ensure proper functioning of DG sets, transformers, and substations. 3. Installation & Commissioning Support installation and commissioning of electrical systems for new process equipment. Ensure wiring diagrams, load calculations, and cable schedules are up to date. 4. Compliance & Documentation Maintain records of preventive maintenance, breakdown reports, and calibration of electrical instruments as per GMP. Ensure compliance with statutory norms (Electrical Inspectorate, ISO, cGMP, EHS). Support audits (internal, regulatory, EHS) with required documentation. 5. Energy Management & Safety Implement energy-saving initiatives and monitor electrical consumption. Ensure electrical safety practices, grounding systems, and protection devices are in place. Conduct safety training and toolbox talks for electrical operations. Qualifications & Experience Education: Diploma / B.E. / B. Tech in Electrical Engineering. Experience: 3 to 8 years (preferably in API / Bulk Drug / Chemical manufacturing). Knowledge of: Electrical maintenance, PLC basics, industrial wiring, DG & transformer operation, cGMP requirements. Skills: Fault finding, preventive maintenance scheduling, documentation, vendor coordination. Key Competencies Strong technical knowledge of plant electrical systems and controls. Awareness of GMP, safety, and statutory electrical norms. Quick problem-solving ability under breakdown situations. Good coordination skills with Production, QA, EHS, and Vendors.

Key Responsibilities 1. Maintenance & Troubleshooting Perform preventive, predictive, and breakdown maintenance for mechanical equipment such as reactors, centrifuges, dryers, heat exchangers, pumps, agitators, boilers, and compressors. Diagnose and rectify mechanical faults to minimize downtime. Maintain mechanical seals, bearings, gaskets, and alignment of rotating equipment. 2. Utilities & Facility Management Monitor and maintain utility systems (chilled water plant, air compressors, boilers, cooling towers, water treatment plants). Ensure energy efficiency and reliability of utility systems. 3. Equipment Installation & Commissioning Participate in installation, commissioning, and validation of new equipment. Ensure mechanical drawings and documentation are updated. 4. Compliance & Documentation Maintain maintenance logs, calibration records, and mechanical drawings as per GMP requirements. Adhere to safety, health, and environmental regulations (OSHA, ISO, cGMP). Support engineering audits and provide necessary documentation to QA and regulatory authorities. 5. Continuous Improvement Identify and implement modifications to improve efficiency, safety, and reliability of mechanical systems. Support projects related to capacity enhancement, energy savings, and automation. Qualifications & Experience Education: Diploma / B.E. / B.Tech in Mechanical Engineering. Experience: 3 to 8 years (preferably in API / Bulk Drug / Chemical manufacturing). Knowledge of: GMP, mechanical maintenance, utility systems, engineering drawings, root cause analysis. Skills: Problem-solving, preventive maintenance planning, documentation, vendor coordination. Key Competencies Strong technical knowledge of mechanical equipment used in pharma API plants. Ability to work in a cross-functional team with Production, QA, EHS, and Stores. Hands-on troubleshooting skills. Awareness of cGMP and regulatory compliance. Safety-conscious mind set.

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

1. Manufacturing Operations & Compound Processing 2. Documentation & Batch Records . GMP implementation 3. Quality, Safety & Compliance 4. Equipment Maintenance & Calibration pharmaceutical Line

We are looking a skilled and motivated Executive IT (GMP Operations) with 3 to 5 years of experience for our Manufacturing Unit (Karakhadi Plant) The candidate will handling IT systems within GMP-regulated environments and support QC and Manufacturing IT operations with a strong focus on compliance, data security, and system integration. Key Responsibilities: Oversee IT GMP operations for QC and Manufacturing systems. Manage user access , data security , domain controllers , and backups . Integrate manufacturing equipment with IT systems and ensure GxP system compliance. Administer QC and Manufacturing applications like Chromeleon, Empower , etc. Operate and support SCADA, HMI , and other manufacturing systems. Ensure IT infrastructure qualification and regulatory compliance . Implement and configure Manufacturing/QC GxP systems . Maintain IT SOPs and ensure compliance during regulatory audits (USFDA, etc.). Communicate effectively and demonstrate leadership in cross-functional Candidate Profile: Bachelor's in IT, Computer Science, or related field. 35 years in pharma IT within a GMP environment . Strong understanding of 21 CFR Part 11, GAMP 5, Annex 11 , etc. Experience with regulatory audits and IT compliance. Good problem-solving, communication, and leadership skills . Interested candidates can share their updated resume at "I tcv@alembic.co.in" with the subject line "Executive IT (GMP Operations)"

Handle QMS, change control, audits, CAPA, deviations, SOPs, vendor docs, training, review BPRs/STPs, stability, validations & master docs.

Responsibilities: Initiation/Review of change control, impact assessment and management of change control records. Preparation of Annual Product Quality Review & MRM record. Review of Vendor questionnaire and related documents. Handling of deviation, market complaints, out of specification and CAPA. Review of Investigation of Deviation, OOS & Other Non-Conformities. Review Of Validation, Qualification CSV Document. interested candidates can share resume to hr3@sarthee.com or call at 9033033650