307 Gmp Compliance Jobs

Looking for an MES Integration Developer skilled in configuring and integrating MES platforms (Rockwell FTPS, Siemens Opcenter, Werum PAS-X, GE Plant Apps) with ERP/LIMS/SCADA using APIs, OPC UA, SQL, and scripting for pharma automation.

JOB DESCRIPTION: Primary Job Function: TPM's supplying to Biosimilars in India and APAC region Quality Oversight of TPM's QMS Management at TPM's Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility Investigations of Products failures, OOS, Complaints pertaining to Abbott products Review of APQR's GMP compliance at TPMs. Compliance to Abbott procedures and policies. Core Job Responsibilities: Responsible and accountable for the oversight of quality operations and GMP compliance across the TPM's under responsibility of EPD Biosimilars Operations in India. Effectively monitoring the rating of responsible TPM sites. Leading the implementation of quality st...

The Engineering Manager will lead the engineering and maintenance functions for the Oncology Manufacturing Facility, ensuring reliability, compliance, and operational excellence. The role requires deep expertise in sterile and injectable pharmaceutical environments, with a strong focus on equipment performance, utilities management, and team leadership. Key Responsibilities: 1. Maintenance and Reliability Management Oversee maintenance operations to ensure optimal performance of production equipment, including lyophilizers, injectable filling lines, and rapid mixer grinders. Develop and execute preventive maintenance programs to minimize downtime and ensure uninterrupted manufacturing. Monit...

Job Title : Chemical Engineer API R&D Location : Kolkata Department : Research & Development (API) Reports to : R&D Manager / Head Process Development Employment Type : Full-Time Key Responsibilities Develop and optimize synthetic processes for APIs at lab and kilo scale in collaboration with chemists and process scientists. Design experiments using DoE (Design of Experiments) and perform reaction engineering studies for critical unit operations. Evaluate process scalability, safety, and sustainability for seamless technology transfer to the manufacturing plant. Perform material and energy balance, process simulation, and equipment sizing. Develop and maintain process documentation: PFDs, P&...

Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...

As an Executive/Senior Executive in the R&D Quality-CMC QA department at Gurugram location, your role involves the following responsibilities: - Review various R&D documents including stability data, analytical reports, method qualification reports, method verification reports, method validation protocols & reports, working standard / impurity standard profile, analytical data of pilot bio batches, and method transfers protocol & report. - Review lab events, deviations, change controls, CAPA, and associated investigation reports before Technology Transfer. - Support and actively participate in failure investigations, identifying root causes for issues related to systems and products develope...

As a candidate for this position, you should have 3-5 years of hands-on experience in Granulation, Compression, and Coating processes. Your role will involve utilizing your good machine handling skills, specifically with RMG, FBD, Compression, and Coating equipment. Key Responsibilities: - Monitor and supervise production processes - Maintain online documentation - Ensure compliance with SOP and GMP standards - Prepare and review SOP, BMR, and BPR - Demonstrate skill in handling manpower - Plan and execute production activities - Utilize Pharma Cloud software for work tasks Qualifications Required: - 3-5 years of experience in Granulation, Compression, and Coating - Proficiency in machine ha...

Role Overview: As a member of the manufacturing team in the Life Sciences sector located at DALC in Navi Mumbai, your primary responsibility will be to ensure manufacturing processes are conducted according to standard operating procedures (SOP) and projects are completed in a timely manner. You will be involved in planning and executing product manufacturing, reviewing and monitoring manufacturing activities, ensuring GMP compliance, validation, and audit readiness. Key Responsibilities: - Plan and execute product manufacturing by facilitating operation and changeover of process systems, debottlenecking process hurdles, and coordinating with the operation team, QAD, and supporting functions...

We are hiring dynamic and self-motivated individuals to work in our Production Department , focusing on manufacturing pharmaceutical products in compliance with quality and safety standards. Key Responsibilities: Operate, monitor, and maintain production equipment as per SOPs. Handle production activities, including granulation, compression, coating, filling, and packing processes. Ensure adherence toGood Manufacturing Practices (GMP ) and regulatory guidelines. Maintain accurate production documentation, including batch manufacturing records and logbooks. Monitor and control production parameters to achieve desired product quality and efficiency. Participate in troubleshooting equipment iss...

Plant Head Location - Kheda, Gujrat Industry - pharmaceutical packaging companies. Open to candidates from rubber manufacturing, pharmaceutical, and medical device industries. Experience - 15+ years Budget - upto 25 LPA Position Overview The Plant Head will provide overall leadership for manufacturing operations, ensuring efficient production of high-quality rubber pharmaceutical packaging products while maintaining safety, quality, and regulatory compliance standards. Key Responsibilities Operations Leadership : Direct all plant operations including production, quality, maintenance, and safety functions Strategic Planning : Develop and implement plant strategies aligned with business object...

Assist in the planning, designing, and drafting of HVAC layouts, duct routing & Cleanroom systems utility designs for pharma & industrial projects apply cleanroom classifications (ISO 14644, GMP) Drawings using AutoCAD or relevant design software

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725

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 em...

Required Experience: 2 to 6 years of hands-on experience in Downstream Processing Educational Qualifications: B.Sc / M.Sc in Life Sciences ITI / Diploma B. Pharmacy / M. Pharmacy B.Tech / Any relevant technical degree Key Skills & Responsibilities: Experience in handling equipment such as: Chromatography columns and systems Column Packing (BPG and Chromoflow) TFF (Tangential Flow Filtration) Systems Centrifuge Systems Filtration, Filter Integrity Testing, Buffer Preparation, CIP/SIP Systems Strong documentation skills QMS/GMP Compliance and process awareness Candidate Preferences: Immediate joiners are highly preferred Only male candidates are encouraged to apply Candidates with prior biolog...

Job Summary: The Production Shift In-Charge DSP is responsible for leading all downstream processing operations during the assigned shift to ensure consistent, efficient, and GMP-compliant production of biological products (e.g., monoclonal antibodies, vaccines, recombinant proteins). The role involves supervising the purification process, managing manpower, ensuring equipment readiness, and maintaining quality and safety standards. Role & responsibilities Key Responsibilities: 1. Shift Operations Management Supervise all downstream production activities, including harvest, filtration, chromatography, ultrafiltration/diafiltration (UF/DF), and formulation. Ensure batch manufacturing records ...

Job Summary: The Production Shift In-Charge USP is responsible for leading and supervising all upstream production activities during the assigned shift. This includes overseeing Microbial / mammalian operations, ensuring compliance with cGMP and safety standards, managing manpower, and ensuring smooth execution of the batch as per the production schedule and approved procedures. Role & responsibilities 1. Shift Operations Management Supervise and coordinate all upstream (USP) production activities during the shift, including media preparation, seed train, bioreactor operations, and harvest. Ensure adherence to batch manufacturing records (BMR), SOPs, and GMP guidelines. Monitor and record al...

Job Title: Senior QC + QA Trainer (Pharma / Biotech Laboratory) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced and knowledgeable QC + QA Trainer to design, develop, and deliver technical training programs for quality control and quality assurance teams. The trainer will be responsible for building competence in analytical testing, documentation practices, GMP compliance, and QA/QC systems within a regulated laboratory environment. Key Responsibilities: Training & Development Develop and deliver structured training programs on QC laboratory techniques, QA systems, and GMP compliance . Conduct practical laboratory training (analytical instruments, wet che...

As a Sr. Manager in Sun Pharma Laboratories Ltd at Guwahati Plant, your role will involve overseeing the entire OSD & NOSD functions of the plant. Your key responsibilities will include: - Coordinating with production & project personnel, contractors, and machine manufacturers to address machine-related problems and implement modifications for smooth process running. - Tracking and maintaining critical spares for preventive and routine maintenance. - Ensuring safety in the working environment by implementing EHS policies. - Responsible for sourcing machine, tooling, consumable parts, and related services, and analyzing required materials. - Handling customer audits and implementing correctiv...

As a Sr. Specialist in Manufacturing Automation, you will be at the forefront of advancing Digital Shop Floor technologies, collaboration, and leadership within your organization. Your primary focus will be on the automation systems installed globally across Animal Health vaccine, biologics, and small molecule manufacturing areas. Your responsibilities will include providing technical guidance on PLC and SCADA technologies, leading sub-teams, implementing proof of concepts, and consulting on solutions. Additionally, you will support site operational teams in addressing day-to-day challenges related to lifecycle management and work closely with various stakeholders to ensure high operational ...

1. Quality System Management: Establish, implement, and maintain the Quality Management System (QMS) as per cGMP, WHO, and regulatory norms . Oversee activities related to change control, deviations, CAPA, OOS/OOT investigations, and risk assessments . Ensure all QA processes align with company policies and current regulatory requirements. 2. Documentation & Compliance: Review and approve SOPs, BMRs, BPRs, validation protocols , and analytical reports. Ensure all documentation complies with Good Documentation Practices (GDP) and data integrity requirements. Supervise document control , issuance, archival, and version management systems. 3. Batch Release & In-Process Quality Assurance: Ensure...

overseeing the large-scale production of tablets, ensuring GMP, managing day-to-day operations, preparing & weighing RM, operating and monitoring equipment, maintaining batch records, and ensuring equipment is clean, maintained, and calibrated.

Key Responsibilities: Preparation, review, and control of Master Formula Records (MFRs) and Batch Manufacturing Records (BMRs). Identification, drafting, review, and periodic revision of Standard Operating Procedures (SOPs) across departments. Compilation and preparation of Annual Product Quality Review (APQR) reports. Preparation, review, and execution of Qualification & Validation documents (equipment, utilities, process, cleaning, etc.). IPQC management ensure in-process checks are conducted as per defined procedures and documented appropriately. Ensure timely product release as per defined process and quality requirements. Work on company-wide quality strategies aimed at reducing non-com...

Job Description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Solid Orals Predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, interpretation and review o...

Senior Officer QA (QMS) 1 Post based in Kathua, Jammu & Kashmir. The ideal candidate brings 4 - 6 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...