123 Gmp Compliance Jobs - Page 2

Role & responsibilities: To maintain the laboratory with respect to availability of chemicals, reagents, glass wares, working standards and reference standards etc. To see that all the instruments logbooks are maintained. To complete the reports of Stability/Raw material/In-process/Intermediate/Finished goods. To make entry of plant samples in the relevant registers. Calibration of QC instruments and Stability chamber. To maintain the cleanliness in the quality control department. To perform analytical method validation. To prepare the analytical protocols and reports of validation. To perform Stability sample Analysis. To perform analysis of cleaning samples. Destruction of Intermediate, Raw Material, Finish Product samples and stability sample. To record daily temperature monitoring of wet laboratory, Control sample. Stability Activity sample planning Analysis, Reviewed ,Trend Preparation Reviewed of Stability sample, In process, Intermediate, Finished Goods, Raw Material in GC, HPLC and Weight lab section. Integration and report of Stability Product To check and record of temperature and humidity control in reserve samples room and stability chambers. Stability chamber problem and follow up from vendor. To perform Particle Size Analyzer analysis of In-process and Finished goods material. Calibration of Stability chamber. Preferred candidate profile: 3-6 Years of experience in Quality Control. B.sc /M.sc (Chemistry) Strong knowledge of method validation, GMP compliance and Stability section.

Supervise entire plant operations and manpower management at Byadgi unit. Data collection & compiling. Prepare reports. Responsible for food safety practices, GMP. Required Candidate profile B.E. or Diploma in Chem/Mech or M.Sc. Food Technology with 2-6 years' exp. Work in shifts. Knowledge of food safety, GMP. Exp in food/pharma/solvent extraction/continuous process industry.

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

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

Looking for a Sr. Admin Executive to handle daily admin and facility operations at our Palghar plant. Key duties include maintaining cleanliness, SOP compliance, supervising housekeeping, managing inventory, and coordinating factory AMC follow-ups. Required Candidate profile similar role, preferably in a factory/industrial setting Good knowledge of facility operations, housekeeping, AMC follow-ups & inventory control Willing to visit plant and work from 8:00 AM to 6:00 PM

knowledge of GMP guidelines, CAPA, deviations, change control. Handling SOPs, batch records, validation protocols, audits, regulatory inspections, aseptic practices. Equipment, process, cleaning, and method validation expertise.

Responsibilities: Chromatographic techniques & System Handling Column Packing(BPG & Chromoflow) TFF System Centrifuge System Filtration, Filter Integrity, Buffer Preparation Expertise in Documentation, GMP Compliance

We are looking for an experienced and detail-oriented Quality Assurance (QA) professional to oversee and maintain the quality management system and ensure compliance with statutory and customer standards. Responsibilities: Prepare and maintain all quality manuals, process documents, and standard operating procedures (SOPs). Review and approve process, quality control, maintenance manuals, and batch/lot releases. Investigate deviations, failures, non-conformances, out-of-specification results, and customer complaints; implement corrective and preventive actions (CAPA). Ensure calibration and maintenance of all instruments and test equipment used for inspection and testing. Ensure compliance with statutory and regulatory standards such as ISO and other applicable guidelines. Oversee validation of processes, analytical methods, and equipment, and review validation reports. Approve analytical reports for finished products, ensuring conformity to standards and customer specifications. Maintain proper control over the use of product labels in line with statutory requirements. Ensure proper inspection and test status of all materials in accordance with laid-down procedures. Conduct internal audits for quality systems, monitor corrective actions, and ensure closure. Conduct training programs to enhance quality awareness among staff. Desired Candidate Profile: Proven experience in quality assurance/quality control in [insert industry, e.g., pharma, FMCG, etc.]. Strong knowledge of quality management systems, ISO standards, GMP/GLP compliance. Excellent problem-solving, analytical, and communication skills. Ability to lead internal audits and drive a culture of quality compliance.

Job Title : Sales & Marketing Manager Cleanroom Equipment & Filters Location: Faridabad Department: Sales & Marketing Reports To: Director Sales & Marketing / General Manager Job Summary: We are seeking a proactive and technically sound Sales & Marketing Manager to join our leadership team at the middle management level. The ideal candidate will have a strong background in marketing and sales within the cleanroom, HVAC, filtration, or life sciences equipment industry. This role is responsible for driving sales growth, executing marketing strategies, and managing customer relationships to expand the company’s market share in cleanroom equipment and air filtration products. Key Responsibilities: Marketing: - Plan and execute B2B marketing campaigns including trade exhibitions, digital marketing, product launches, brochures, and email campaigns. - Coordinate with the design and technical teams to develop product presentations, datasheets, case studies, and videos. - Analyze market trends, competitor offerings, and customer feedback to guide product positioning and messaging. - Manage digital presence including website updates, SEO, and LinkedIn campaigns to boost brand visibility. - Maintain marketing collateral in line with technical accuracy and compliance standards (e.g., ISO, GMP). Sales: - Develop and implement sales strategies to meet and exceed revenue targets across product lines including HEPA/ULPA filters, terminal housings, biosafety cabinets, air showers, and cleanroom products. - Identify and acquire new clients in key sectors such as pharmaceuticals, biotechnology, hospitals, electronics, and research labs. - Maintain and strengthen relationships with existing customers, consultants, and channel partners. - Conduct site visits, technical discussions, and product demonstrations to provide value-based solutions. - Prepare and present sales forecasts, pipelines, and performance reports to senior management. - Respond to RFQs, RFPs, and tender documents, ensuring accurate technical and commercial submissions. Team & Coordination: -Create, mentor and Lead a team of sales and marketing executives and coordinate cross functionally with production, design, and service departments. - Ensure timely customer follow-ups, order closures, and post-sales support coordination. - Work closely with the product development team to provide market insights and customer feedback for new products or improvements. - Monitor and manage departmental budgets and ensure efficient resource allocation. Qualifications: - Bachelor’s degree. MBA in Marketing is a plus. - 5–8 years of relevant experience in industrial product sales and marketing, preferably in cleanroom equipment, filtration, HVAC, or life sciences. - Strong technical understanding of cleanroom standards (ISO 14644), air filtration (EN 1822, ISO 16890), and HVAC systems is highly desirable. - Proven ability to handle high-value B2B technical sales and large-scale industrial clients. - Excellent communication, presentation, and negotiation skills. Preferred Skills: - Familiarity with industry-specific compliance standards: GMP, GLP, ISO, NABL, FDA. - Knowledge of CRM systems, digital marketing platforms, and ERP tools. -Proficient in MS office and computer. - Willingness to travel for client meetings, exhibitions, and technical support.

Job Description: Regulatory Affairs Assistant Manager / Manager Injectable & OSD Facility Department: Regulatory Affairs Location: GIDC Ankleshwar Key Responsibilities: Prepare and submit dossiers (CTD/ACTD) for ROW & US markets. Ensure compliance with local regulatory guidelines and GMP standards. Liaise with regulatory agencies and respond to queries promptly. Manage product registrations, renewals, and variations. Monitor regulatory updates and ensure adherence to changes. Support quality audits and review labeling/artwork for compliance .

Position: Production Executive / Officer Injectables Location: Ankleshwar,Gujarat Experience: 2-4 years Key Responsibilities: Carry out production activities as per SOPs and schedule Ensure adherence to cGMP and regulatory guidelines Maintain accurate production documentation (BMRs, logbooks) Coordinate with QA/QC for line clearance and sampling Support equipment cleaning, operation, and minor troubleshooting Follow all safety and hygiene protocols Requirements: B.Pharm/M.Pharm/B.sc/ Msc or equivalent 2- 4years experience in parental production Good knowledge of GMP and pharma documentation Strong attention to detail and communication skills

Identify new CMO manufacturers to provide on P2P basis products in S Kant Brand. Evaluate potential CMO on commercial and technical aspects Post confirmation of CMO, to organize audit of CMO and work with SKant quality teams for GMP compliance of the CMO Periodic visits to the CMO and visits during initial batch manufacturing for S Kant brand Coordinate with CMO & S Kant RA Team for dossier preparation and compilation Work with CMO for Investigation and CAPA of market complaints

Role & responsibilities We are looking a candidate who can work independently at our API Mfg plant which will cover IT Infra, CSV, ERP implementation, GMP compliance, etc. Implementation and roll out of all IT Application and Infrastructure initiatives at the site Deployment, monitoring, maintenance, security, data backup, development, upgrade, and support of all IT systems including Servers, Telephones, network elements, PCs. Operating systems, hardware, software, and other peripheral equipment. Responsible for day-to-day system administration, including management of internal network, VPN, Microsoft Active Directory (AD) and system backups. Implement IT policies, procedures, and best practices, working closely with management to help maintain compliance on all IT infrastructure and applications as needed. Plan and coordinate IT-related activities, provide direction and support for daily and mission-critical operational activities of the IT department. Work with users to define business and system requirements for new technology implementations. Coordinate with cross-functional module leads and continuous monitoring and system development. Thorough understanding of CSV process, GMP Compliance, CFR compliance, etc. Management of IT Infrastructure (Servers, Virtualization, software, Network and RDBMS) Stakeholder & Vendor Management ERP Implementation & UAT for various modules i.e. Manufacturing, HRMS, Quality, etc. Working Location : Zekda, Dist: Bavla, Ahmedabad

Role & responsibilities Primarily responsible for operation and clearing of Capsule machine. Prepare the BMR and Logs-books and records of equipment and Batches. Maintain safety and clean work environment by following current GMP. Should have knowledge of BMR, BPR preparations and maintain staff record. Preferred candidate profile OSD Experience is must. Good understanding of cGMP and safety procedures.

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

We are looking for Senior Automation Engineer to join our growing India operations. The candidate for this position will support the BioPharma industry projects. Note: this is not IT software test engineering position. Below are broad requirements and qualifications The candidate should have strong domain expertise related to process automation, process controls, and instrumentation. Ideal candidate will have 7 to 12 years of industry experience, 3+ years related to Pharma or Biotech industry. either directly with Bio/Pharma company, or with one of the system integration houses, or with OEM equipment fabricators. Experience with PLC-SCADA, DCS, Data Historians, IT hardware, network infrastructure. On common platforms including from Rockwell, Siemens, Emerson, etc. Possess knowledge of industry guidelines (example, ISA and GAMP) and regulations (example: US CFRs related to highly regulated Pharma industry), data integrity. Given our business model, soft skills including: communication, collaborative mindset, critical thinking, affinity for business development will help propel career growth. Familiarity with process unit operations, applications, use cases, industry trends, etc. are pluses, but not necessarily prerequisites as long as the candidate has strong core automation skills and is a good cultural fit for the position. XenPharm will provide plenty of opportunities to learn these aspects on the job. Responsibilities Independently lead the automation scope of our projects, under the direction of project lead or principal consultant. Typical project examples: conceptual / basic design of Bio/Pharma facilities, owning the core process automation, upgrade of existing or legacy plants, data acquisition and historian system implementation.

Overseeing the quality assurance function at our manufacturing sites located in Baddi & Rudrapur. Ensure that all products manufactured at the sites adhere to the required quality standards, regulatory requirements, and internal procedures. Required Candidate profile M.Sc/B.Pharm/M.Pharm 12+ year QA experience in a regulated pharma/CDMO environment Strong knowledge of cGMP, ICH & regulatory guidelines Hands-on experience in audits, documentation, quality systems

Job Title: Research Assistant Quality Control (QC) Department: Quality Control Location: Noida Company: Advancells Group Salary Range: 25,000 - 40,000 per month Preference : Male Candidate, Immediate Joiner About Advancells Group: Advancells is a pioneering leader in stem cell manufacturing and regenerative medicine. Our mission is to bring cutting-edge biomedical science into practical application for patient well-being and healthcare innovation. As part of our growth, we are hiring passionate professionals to join our Quality Control team. Role Overview: We are looking for a committed and detail-oriented Research Assistant QC to support on-site quality control operations, microbiological testing, and packaging inspection activities. The role will involve hands-on testing, documentation, and collaboration with the production team to uphold product quality and GMP compliance. Key Responsibilities: Perform microbiological testing on raw materials, in-process samples, and finished goods. Conduct Sterility Testing and Bacterial Endotoxin Testing (BET) as per pharmacopeial and SOP standards. Execute and record Quality Control checks for product packaging and labeling. Support in-process quality checks on production floor to ensure hygiene and GMP adherence. Conduct visual and physical inspections for finished product quality parameters. Perform routine environmental monitoring , cleanroom checks, and personnel hygiene audits. Assist in line clearance activities before and after batch production. Participate in root cause analysis of non-conformities, especially related to packaging or contamination issues. Ensure Good Documentation Practices (GDP) while recording observations and test results. Be available for on-site physical tasks such as sampling, validations, and quality checks during production. Support field activities such as transporting samples, overseeing external testing, and maintaining sample integrity. Candidate Requirements: Qualification: M.Sc. in Microbiology / Biotechnology / Life Sciences (preferred) Experience: 13 years in QC/QA roles within pharmaceutical, biotech, or stem cell environments. Strong understanding of GMP, GDP, and QC protocols . Hands-on experience in microbiological testing and working in cleanroom environments . Good interpersonal skills and ability to coordinate with production and documentation teams. Immediate joiners will be given preference. Why Join Us? Be part of India's leading organization in regenerative medicine. Work in a GMP-certified lab environment with world-class QC standards. Growth opportunities in a fast-evolving biomedical industry. How to Apply: Send your updated resume to hr@advancells.com with the subject line: Application for Research Assistant QC . Immediate joiners will be prioritized.

Maintain the documents as per systems related to cGMP for various statutory and regulatory audits and inspections. To actively participate in process validation as well as cleaning validation activity and environmental monitoring as per plan.

Maintain the documents as per systems related to cGMP for various statutory and regulatory audits and inspections. To actively participate in process validation as well as cleaning validation activity and environmental monitoring as per plan.

AM QC Chemist for Agro chemical Industry In Saykha,Bharuch, Gujarat Job Title: Executive/Sr Executive Department: QC Experience Required: 5 to 10 years Industry Manufacturing Production Quality Qualification M.Sc Key Skills Agro Chemical QC Chemist Quality Control Executive QC UPLC HPLC GC Agro GMP Compliance We are looking for a skilled Am QC Chemist to join our team in the Agro Chemical Industry. The ideal candidate will have 6-12 years of experience and be based in [location to be specified]. Roles and Responsibility Conduct quality control tests on agrochemical products to ensure they meet industry standards. Develop and implement quality control procedures to minimize defects and improve product quality. Collaborate with cross-functional teams to resolve quality-related issues and enhance overall product quality. Analyze data from quality control tests to identify trends and areas for improvement. Maintain accurate records of quality control activities, including test results and corrective actions. Ensure compliance with regulatory requirements and industry standards. Job Requirements Bachelor's degree in Chemistry or related field. Proven experience in quality control within the agrochemical industry. Strong knowledge of quality control principles, practices, and regulations. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Effective communication and interpersonal skills. Familiarity with industry-specific software and technologies.

We are looking for a skilled QA Executive to join our team in the Agro Chemical Industry in Saykha, Bharuch, Gujarat. The ideal candidate will have 2-7 years of experience in quality assurance and control. Roles and Responsibility Develop and implement effective quality control processes to ensure high-quality products. Conduct regular audits to identify areas for improvement and implement corrective actions. Collaborate with cross-functional teams to resolve quality-related issues. Analyze data to identify trends and opportunities for quality improvement. Develop and maintain quality control documentation and records. Ensure compliance with industry regulations and standards. Job Requirements Bachelor's degree in any discipline. Proven experience in quality assurance and control. Strong analytical and problem-solving skills. Excellent communication and collaboration skills. Ability to work in a fast-paced environment and meet deadlines. Familiarity with industry-specific software and technologies.

QA Executive For Agro chemical Industry In Saykha,Bharuch, Gujarat Bharuch, Ahmedabad, Vadodara Job description Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Required Candidate profile Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility

Compliance of GMP & GMP Documents, GRN Preparation, Receipt, Handling and Issuance of Material. Manpower Utilization Skills, Compliance with Internal as well as External Audits, Dispensing of Materials. ERP System, Follow and Implementation Required Candidate profile B. Com / B. Sc / Diploma Material management

Responsibilities: Lead factory ops, ensure GMP compliance & ISO doc prep. Collaborate with R&D on new product launches & scale-up plans. Oversee API manufacturing processes & quality control measures.