Performing tests on raw materials, in-process samples, and finished products to ensure they meet quality standards. Analyzing test results, identifying deviations, and generating reports to track quality trends and performance Reviewing manufacturing processes, identifying areas for improvement, and making recommendations to enhance product quality. Maintaining accurate records of testing procedures, results, and deviations, ensuring compliance with Good Manufacturing Practices (GMP). Participating in internal audits and ensuring compliance with regulatory requirements and company policies. Working with cross-functional teams, such as manufacturing, research and development, and regulatory affairs, to ensure quality standards are met. co-ordinate with production department and to involve in various activity related to facility, utility, equipment’s & products for its designing, installation and qualification activities and to contribute cGMP point of view in all these areas. Review of critical quality functions such as deviations, change controls, out-of-specification events, annual product reviews and to take proactive actions. To Review evaluate of product quality Utility Quality records, area monitoring records, Batch Record, QA/QC Report. Job Type: Full-time Pay: ₹15,000.00 - ₹22,000.00 per month Benefits: Health insurance Paid sick time Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Education: Bachelor's (Preferred) Work Location: In person
Maintain consistent and document compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements. To perform analytical characterisation and data analysis in a timely manner and to a high standard. Perform all Quality Control duties and tasks in accordance with relevant GMP guidelines. Calibration and monitoring of analytical equipment. Perform laboratory investigations and out of specification investigations to GMP standards To review the sampling and testing activity of RM, PM and FP sample. To release the sample for manufacturing and prepare COA. To procurement of laboratory chemical, glassware, equipments spares and consumable items related to analytical and microbiological section. Develop and maintain quality documentation, including inspection reports and quality control records Monitor product and process performance to identify areas for improvement Investigate and resolve customer complaints related to quality Job Type: Full-time Pay: ₹15,000.00 - ₹20,000.00 per month Benefits: Health insurance Paid sick time Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Education: Bachelor's (Preferred) Experience: QC: 1 year (Preferred) Work Location: In person
· Analyze the data thoroughly to find the areas of growth · Develop strategies to improve the production process · Eyeing on the objectives to maximize the profitability of the organization · Providing training to individuals who handle the product · Make sure whether the product goes through auditing and testing · Formulate timely reports and documentation to track progress · Identify the training requirements to meet the quality standards · Make documentation of internal audits and quality assurance activities · Plan, conduct, and monitor the test, and inspect the products to ensure their quality · Take a look at customer complaints · Analyze the data to find the areas for improvement Quality assurance knowledge of tools and methodologies Audit and Compliance Job Type: Full-time Pay: ₹20,000.00 - ₹35,000.00 per month Benefits: Health insurance Paid sick time Paid time off Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Education: Master's (Preferred) Experience: Quality Assurance Managment: 5 years (Preferred) Language: Hindi, English (Preferred) Location: Vejalpur, Gujarat (Preferred) Work Location: In person
Manage accounts payable and receivable processes. Reconcile bank statements and resolve any discrepancies Maintain the general ledger and ensure all financial transactions are accurately recorded. Perform month-end and year-end closing activities. Prepare and submit tax returns and other statutory filings. Support internal and external audits by providing necessary documentation and information. Work closely with other departments to ensure accurate and timely financial information. Communicate effectively with team members and management Job Types: Full-time, Permanent Pay: ₹12,000.00 - ₹16,000.00 per month Benefits: Health insurance Paid sick time Paid time off Provident Fund Schedule: Day shift Morning shift Supplemental Pay: Yearly bonus Education: Bachelor's (Preferred) Experience: Tally software: 1 year (Preferred) Language: English (Preferred) Work Location: In person
Manage accounts payable and receivable processes. Reconcile bank statements and resolve any discrepancies Maintain the general ledger and ensure all financial transactions are accurately recorded. Perform month-end and year-end closing activities. Prepare and submit tax returns and other statutory filings. Support internal and external audits by providing necessary documentation and information. Work closely with other departments to ensure accurate and timely financial information. Communicate effectively with team members and management Job Types: Full-time, Permanent Pay: ₹12,000.00 - ₹16,000.00 per month Benefits: Health insurance Paid sick time Paid time off Provident Fund Schedule: Day shift Morning shift Supplemental Pay: Yearly bonus Education: Bachelor's (Preferred) Experience: Tally software: 1 year (Preferred) Language: English (Preferred) Work Location: In person
Supervise the finished product labeling and packaging of medical devices, and the product packaging in blister or pouches in control environment Creates and modifies labeling for finished products and other related materials following the established design format, labeling style guidelines, and branding guidelines. Works with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives. Creates and manages labeling change requests within the document management system. Ensure all activities are performed in accordance cGMP’s. Write and update SOP’s pertaining to department activities. Recommend and implement production process improvements to improve quality, reduce cost, and improve safety. Identify the developmental needs of others and provide coaching, mentoring, and encouragement to help others to improve their knowledge or skills. Initiate, recommend, or provide solutions through designated channels. Job Types: Full-time, Permanent Pay: ₹12,000.00 - ₹22,000.00 per month Benefits: Food provided Health insurance Paid sick time Paid time off Provident Fund Schedule: Day shift Morning shift Supplemental Pay: Yearly bonus Education: Bachelor's (Preferred) Experience: Pharmaceuticals: 1 year (Preferred) Work Location: In person
The role involves supervising the labeling and packaging of medical devices in a controlled environment. This includes overseeing the packaging of products in blister or pouches. You will be responsible for creating and modifying labeling for finished products, ensuring adherence to design and branding guidelines. Collaborating with various departments to address labeling inconsistencies and meet project objectives is an essential part of the role. Managing labeling change requests within the document management system is also a key responsibility. Ensuring that all activities comply with cGMPs and writing/updating SOPs related to department activities are crucial aspects of the position. You will be expected to recommend and implement process improvements to enhance quality, reduce costs, and improve safety measures. Identifying the developmental needs of team members and providing coaching and mentoring to support their growth is also part of the role. Additionally, suggesting solutions through designated channels is an important aspect of the job. This is a full-time, permanent position with benefits including food provision, health insurance, paid sick leave, paid time off, and a Provident Fund. The work schedule consists of day and morning shifts with a yearly bonus. The preferred education level for this role is a Bachelor's degree. Previous experience in the pharmaceutical industry is preferred, with at least 1 year of relevant experience. The work location is in person.,
As a Quality Assurance Manager, you will be responsible for analyzing data thoroughly to identify areas of growth and developing strategies to enhance the production process. Your objective will be to maximize the profitability of the organization by providing training to individuals handling the product, ensuring that products undergo auditing and testing, and formulating timely reports to track progress. You will be tasked with identifying training requirements to meet quality standards, documenting internal audits and quality assurance activities, planning, conducting, and monitoring tests to inspect products for quality assurance. Additionally, you will be required to investigate customer complaints and analyze data to pinpoint areas for improvement. The ideal candidate will possess knowledge of quality assurance tools and methodologies, as well as have experience in audit and compliance. This is a full-time position with benefits such as health insurance, paid sick time, paid time off, and a provident fund. The work schedule is during the day shift, with a yearly bonus provided. Preferred qualifications include a Master's degree, 5 years of experience in Quality Assurance Management, proficiency in Hindi and English languages, and the ability to work in person at the Vejalpur, Gujarat location.,
Verification of calibration, cleaning of instruments and manufacturing equipments. Participation in technology transfer process from F & D and other manufacturing site. To ensure implementation of quality manual/quality policy, guidance documents and directives. To monitor changes in the official monographs and ensuring its implementation at sites. To conduct the internal audit, lead the site for external audits and their compliance. To ensure personnel training and its evaluation at site. Vendor qualification. Approval of technical agreements. To ensure issuance, control and retrieval of art work and shade card. Responsible for risk assessment studies. Responsible for investigation and closing of OOS, OOT, deviation, incident, change control and market complaints. Responsible for preparation & review the license application to FDA for additional products, COPP, FSC and other FDA related documents before submission. To ensure the accuracy, integrity, legibility and availability of documents. Instruction documents should be free from errors and available in writing. Any activity covered by the GMP guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid any misunderstanding which could result in a product or operation of unsatisfactory quality. QA Head/Designee: Responsible for overall quality of products and compliance of GMP at the site. To coordinate with Production, HR, Engineering, QC and Warehouse departments. Shall be the approving authority for all the master documents such as BMR, BPR SOPs, qualification documents of analytical and manufacturing equipments, specifications, COA, validation protocols, Market complaints, deviation/Incidents, change control, CAPA, OOS and OOT results. Release the batches for distribution. Coordination with cross functional team, RA, F & D for Review & approval of analytical technology transfer and method validation documents. To evaluate and authorize rework or reprocessing of the batch. Responsible for approval of technical agreements. Responsible for approval of Site Master File,VMP,QM, SOPs, SM, TM & other documents. Responsible for approval & investigation of the market complaint and prepare response and forward it for further review. To approve the CAPA and comment on the same. Ensure implementation of CAPA. To decide, monitor & ensure the batch recall. Coordination with Regulatory Affairs for preparation and filling of dossiers. To liaison with local FDA for inclusion/grant of license and certifications. To lead the site for internal, external GMP audits and their compliance. To approve the qualification, validation and revalidation activities and their compliance at the site as per validation master plan. To ensure personnel training and its evaluation at site. To ensure the shop floor activities and ensure day to day compliance. To interact with F & D, Purchase, RA for artwork, vendor qualification and other non conformance issues related to products manufactured at the site. To coordinate with HR for recruitment of QA personnel and their induction training. To control the budget expenditure. Approval of self-audit action plan. Approval of destruction/disposal. Collecting information and providing Guidelines for personnel knowledge update through information sharing and /or trainings. Advising on training requirements, conducting training on Quality Manual /Quality Policy and monitoring the training activity in the company. Support preparation of training modules and circulating the same to sites. Suggesting improvements in product presentation/ packing /quality. To monitor changes in the official monographs, guidelines and ensuring its implementation at sites. Evaluation & approval of risk assessment in the site. To ensure the compliance with validation master plan and requalification of utility, equipments, procedures and systems as per the frequency described. To ensure the protocols, related qualification, validation documents and their summary report and related formats of engineering, manufacturing and testing instruments. To conduct vendor audits. Appraise customer’s requirements and make sure they are satisfied. QA Asst. Manager/Designee: Preparation of Site Master File, VMP, QM, SM, TM & other documents. Monitoring and review of annual product quality review. To involve in quality control functions and ensure GLP and data authenticity. To ensure issuance, control and retrieval of Art work and shade card. To review the executed worksheets / specifications of raw material, packing material, semi-finished and finished product. To review the batch documents and QC data and give clearance for release for finished products. Review of stability protocols and stability data with coordination of QC and inform to QA head/Designee about the outcome of the stability data and submit to RA for dossier submission purpose. Review of calibration records of analytical instruments. To monitor changes in the official monographs and inform to QA Head/Designee. To review the SOPs and its implementation. To ensure the in process testing and compliance during operations. To evaluate and approve extra material/ excess return request made by production. To assist in investigation of the deviations/ incident, non conformances, market complaint, OOS and OOT. To support preparations at site for external audits. Help in preparation of compliance reports. To review the change control proposed and to ensure closure of the change controls, post implementation after conducting impact assessment. To prepare monthly report and furnished required information to QA Head /Designee. To coordinate and conduct internal audits of GMP compliance. Allocate the responsibility to the IPQA team for the shift operations if applicable. To conduct training for IPQA personnel. Click the link for download word file copy of this document: https://pharmaguidehub.com/product/responsibility-of-qa-in-pharmaceutical/ To prepare answers to the queries received from Regulatory agencies on the submissions and RA send the draft for review to QA. On confirmation prepare the final version and send it to Regulatory Affairs department, for onward submission to respective Regulatory agencies. To prepare & review the license application to FDA for additional products, COPP, FSC and other FDA related documents before submission. In the absence of QA head/Designee, the responsibility shall be delegated upward to QA Asst. Manager/Designee. QA Executive/Designee : To develop efficient filling system of all QA documents by assigning file numbering system, prepare master index, lists of documents and ensure correct filing of documents. To maintain, destruction records and ensure safe destruction of obsolete records. Preparation of SOP’s. Preparation & review of master formulae Record. Preparation & Review of batch manufacturing record and batch packing record. Review of scale up (Optimization) activity reports. Assist in execution of validation and qualification activities. Customer complaint investigation. Review of filled BMR/BPR. Logging of CAPA, MC, OOT, OOS, Deviation/Incident, Change control & other documents. Review & compliance of cleanliness and environmental conditions in manufacturing area prior to and during manufacturing. Monitoring of destruction/disposal and reprocessing activities; if any. To Prepare & review of Annual Product Quality Review. To monitor IPQA activities on shop floor randomly. To coordinate for annual training of personnel in the Site. Ensure the maintenance of control sample and stability sample. Responsible for issuance, retrieval, retention and destruction of documents such as Batch Manufacturing Record and Batch Packaging Record, SOP, formats, logbooks, analytical worksheets, specification, Standard testing procedure, General testing procedure, material bin card. QA Officer/ Sr. Officer: To check of cleanliness and environmental conditions in manufacturing area prior to and during manufacturing. To maintain the inward/outward records in the documentation cell. Collection of data for annual product quality review. To carryout Line clearance checks. To carryout In-process checks in Warehouse, manufacturing & Packing departments. To check on line documentation. To check SOP compliance on shop floor. Sampling of semi-finished and finished product. Swab and rinse water sampling. Control sample & Stability sample collection, storage and monitoring. Checking of instrument log books, calibration record & other document in production, QC, Engineering & Warehouse. Job Type: Full-time Pay: ₹15,000.00 - ₹22,000.00 per month Benefits: Health insurance Paid sick time Provident Fund Education: Bachelor's (Preferred) Work Location: In person
Verification of calibration, cleaning of instruments and manufacturing equipments. Participation in technology transfer process from F & D and other manufacturing site. To ensure implementation of quality manual/quality policy, guidance documents and directives. To monitor changes in the official monographs and ensuring its implementation at sites. To conduct the internal audit, lead the site for external audits and their compliance. To ensure personnel training and its evaluation at site. Vendor qualification. Approval of technical agreements. To ensure issuance, control and retrieval of art work and shade card. Responsible for risk assessment studies. Responsible for investigation and closing of OOS, OOT, deviation, incident, change control and market complaints. Responsible for preparation & review the license application to FDA for additional products, COPP, FSC and other FDA related documents before submission. To ensure the accuracy, integrity, legibility and availability of documents. Instruction documents should be free from errors and available in writing. Any activity covered by the GMP guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid any misunderstanding which could result in a product or operation of unsatisfactory quality. QA Head/Designee: Responsible for overall quality of products and compliance of GMP at the site. To coordinate with Production, HR, Engineering, QC and Warehouse departments. Shall be the approving authority for all the master documents such as BMR, BPR SOPs, qualification documents of analytical and manufacturing equipments, specifications, COA, validation protocols, Market complaints, deviation/Incidents, change control, CAPA, OOS and OOT results. Release the batches for distribution. Coordination with cross functional team, RA, F & D for Review & approval of analytical technology transfer and method validation documents. To evaluate and authorize rework or reprocessing of the batch. Responsible for approval of technical agreements. Responsible for approval of Site Master File,VMP,QM, SOPs, SM, TM & other documents. Responsible for approval & investigation of the market complaint and prepare response and forward it for further review. To approve the CAPA and comment on the same. Ensure implementation of CAPA. To decide, monitor & ensure the batch recall. Coordination with Regulatory Affairs for preparation and filling of dossiers. To liaison with local FDA for inclusion/grant of license and certifications. To lead the site for internal, external GMP audits and their compliance. To approve the qualification, validation and revalidation activities and their compliance at the site as per validation master plan. To ensure personnel training and its evaluation at site. To ensure the shop floor activities and ensure day to day compliance. To interact with F & D, Purchase, RA for artwork, vendor qualification and other non conformance issues related to products manufactured at the site. To coordinate with HR for recruitment of QA personnel and their induction training. To control the budget expenditure. Approval of self-audit action plan. Approval of destruction/disposal. Collecting information and providing Guidelines for personnel knowledge update through information sharing and /or trainings. Advising on training requirements, conducting training on Quality Manual /Quality Policy and monitoring the training activity in the company. Support preparation of training modules and circulating the same to sites. Suggesting improvements in product presentation/ packing /quality. To monitor changes in the official monographs, guidelines and ensuring its implementation at sites. Evaluation & approval of risk assessment in the site. To ensure the compliance with validation master plan and requalification of utility, equipments, procedures and systems as per the frequency described. To ensure the protocols, related qualification, validation documents and their summary report and related formats of engineering, manufacturing and testing instruments. To conduct vendor audits. Appraise customer’s requirements and make sure they are satisfied. QA Asst. Manager/Designee: Preparation of Site Master File, VMP, QM, SM, TM & other documents. Monitoring and review of annual product quality review. To involve in quality control functions and ensure GLP and data authenticity. To ensure issuance, control and retrieval of Art work and shade card. To review the executed worksheets / specifications of raw material, packing material, semi-finished and finished product. To review the batch documents and QC data and give clearance for release for finished products. Review of stability protocols and stability data with coordination of QC and inform to QA head/Designee about the outcome of the stability data and submit to RA for dossier submission purpose. Review of calibration records of analytical instruments. To monitor changes in the official monographs and inform to QA Head/Designee. To review the SOPs and its implementation. To ensure the in process testing and compliance during operations. To evaluate and approve extra material/ excess return request made by production. To assist in investigation of the deviations/ incident, non conformances, market complaint, OOS and OOT. To support preparations at site for external audits. Help in preparation of compliance reports. To review the change control proposed and to ensure closure of the change controls, post implementation after conducting impact assessment. To prepare monthly report and furnished required information to QA Head /Designee. To coordinate and conduct internal audits of GMP compliance. Allocate the responsibility to the IPQA team for the shift operations if applicable. To conduct training for IPQA personnel. Click the link for download word file copy of this document: https://pharmaguidehub.com/product/responsibility-of-qa-in-pharmaceutical/ To prepare answers to the queries received from Regulatory agencies on the submissions and RA send the draft for review to QA. On confirmation prepare the final version and send it to Regulatory Affairs department, for onward submission to respective Regulatory agencies. To prepare & review the license application to FDA for additional products, COPP, FSC and other FDA related documents before submission. In the absence of QA head/Designee, the responsibility shall be delegated upward to QA Asst. Manager/Designee. QA Executive/Designee : To develop efficient filling system of all QA documents by assigning file numbering system, prepare master index, lists of documents and ensure correct filing of documents. To maintain, destruction records and ensure safe destruction of obsolete records. Preparation of SOP’s. Preparation & review of master formulae Record. Preparation & Review of batch manufacturing record and batch packing record. Review of scale up (Optimization) activity reports. Assist in execution of validation and qualification activities. Customer complaint investigation. Review of filled BMR/BPR. Logging of CAPA, MC, OOT, OOS, Deviation/Incident, Change control & other documents. Review & compliance of cleanliness and environmental conditions in manufacturing area prior to and during manufacturing. Monitoring of destruction/disposal and reprocessing activities; if any. To Prepare & review of Annual Product Quality Review. To monitor IPQA activities on shop floor randomly. To coordinate for annual training of personnel in the Site. Ensure the maintenance of control sample and stability sample. Responsible for issuance, retrieval, retention and destruction of documents such as Batch Manufacturing Record and Batch Packaging Record, SOP, formats, logbooks, analytical worksheets, specification, Standard testing procedure, General testing procedure, material bin card. QA Officer/ Sr. Officer: To check of cleanliness and environmental conditions in manufacturing area prior to and during manufacturing. To maintain the inward/outward records in the documentation cell. Collection of data for annual product quality review. To carryout Line clearance checks. To carryout In-process checks in Warehouse, manufacturing & Packing departments. To check on line documentation. To check SOP compliance on shop floor. Sampling of semi-finished and finished product. Swab and rinse water sampling. Control sample & Stability sample collection, storage and monitoring. Checking of instrument log books, calibration record & other document in production, QC, Engineering & Warehouse. Job Type: Full-time Pay: ₹15,000.00 - ₹22,000.00 per month Benefits: Health insurance Paid sick time Provident Fund Education: Bachelor's (Preferred) Work Location: In person
Role Overview: You will be supervising the labeling and packaging of medical devices in a controlled environment. This will involve overseeing the packaging of products in blister or pouches. Your responsibilities will include creating and modifying labeling for finished products, ensuring adherence to design and branding guidelines. Collaborating with various departments to address labeling inconsistencies and meet project objectives will be an essential part of your role. Managing labeling change requests within the document management system will also be a key responsibility. Key Responsibilities: - Ensure all activities comply with cGMPs - Write/update SOPs related to department activities - Recommend and implement process improvements to enhance quality, reduce costs, and improve safety measures - Identify the developmental needs of team members and provide coaching and mentoring - Suggest solutions through designated channels Qualifications Required: - Bachelor's degree preferred - Previous experience in the pharmaceutical industry with at least 1 year of relevant experience (Note: Omitting additional details of the company as it was not provided in the job description),