37 Lab Qa Jobs

Role & responsibilities : Responsible for investigation of incidents, OOS, OOT, OOC & Deviation in Laboratory. Responsible for Review and closure of investigation of incidents, OOS, OOT, OOC & Deviation in Laboratory. Responsible for initiation & closure of Change Control, Deviations, CAPA in QEdge Software. Responsible for Review of Standard Operating Procedures and Standard Test Procedures. Responsible for preparation of Protocols, Reports and Annexures Investigation & Documentation. Responsible for Review of analytical documents, and audit trials as per 21 CFR part 11 compliance. Deep understanding of GMP, GLP, ISO 17025, regulatory guidelines, QMS, HPLC, GC, data integrity. Preferred can...

Role & responsibilities To support R&D Executives for all activities as directed • maintain cleanliness of testing equipment • Support chemist in maintaining the records at stipulated & confined area • Provide samples for Testing of incoming RM from trucks Take samples as per given directives from QC chemists • Provide production samples for lab testing • Maintain General Housekeeping of QC Support ISO documentation and filing. 5s, kaizen

Role & responsibilities Preferred candidate profile

Responsible for overall administration and oversight of quality control, quality assurance, and quality improvements at testing laboratory Quality Assurance Laboratory Professionals ( LAB QA) Develop and implement quality assurance protocols, Lead teams in addressing quality-related issues Bachelor degree in Medical Laboratory Technician / M. Sc

Role & responsibilities Handling and upkeep the documentation & record keeping of microbiology. Ensure calibration of equipments as per Frequency Ensure effectiveness of CIP & COP & Sanitation, Steaming, cleaning in all areas. Cross verification of the key micro affecting parameters/process like CIP time, temperature, concentration, chlorine pasteurization temperature, steaming temperature & Time, tilter time & temperature, filling temperature in HF, Hot carbon treatment temperature & contact time, UV lamp intensity & Hours, chlorine interlocks, all process handwash working & availability & usage of Sanitizer. Ensure effectiveness of AHU functioning & cleaning in defined workplace. Ensuring ...

Job Description You will be responsible for ensuring data integrity, maintaining laboratory quality assurance (QA), managing the Quality Management System (QMS), and overseeing audit and compliance activities. Key Responsibilities - Implement and maintain data integrity practices within the laboratory. - Develop and execute QA programs to ensure accuracy and reliability of testing processes. - Manage the QMS to meet regulatory requirements and quality standards. - Conduct internal and external audits to ensure compliance with regulations and industry standards. Qualifications Required - Bachelor's degree in a relevant field such as Chemistry, Biology, or a related discipline. - Experience in...

Establish and maintain QMS in Analytical Dept, ensure cGLP, handle deviations, CAPA, audits, regulatory compliance, COA release, equipment qualification, and drive continuous improvement and customer complaint management. Office cab/shuttle Annual bonus Provident fund Health insurance

Preparation, review and approval of stability summary report. Preparation, review of freeze thaw study protocol and report Preparation, review of temperature cycle study protocol and report. Required Candidate profile To review AMV, STP, specification, worksheet of finished and raw material packaging material & To Review and implement Validation protocol for process, equipment, cleaning and Analytical Validation.

Role & responsibilities 1 )Well versed in the analytical review of documents, which includes of those from GLP section, 2) OOS, OOT, Events, Change control, CAPA related QMS handling 3) Column management, Standard handling, glassware management, chemical management 4) Retention samples management and review of stability sample and study management. To review of stability protocol/summary sheet 5) Computer system validation, calibration & qualification of instruments. Review of audit trail from the computerized systems. 6) Ensure QC laboratory compliance at all times, participate in Lab check rounds. 7) Preparation & review of OOS/OOT/Events trending. 8) Review of analytical documents, chroma...

Role & responsibilities 1. Responsible for functioning of related to review of reports 2. Monitoring of good laboratory practices as laid down in standard operating procedures 3. Monitoring laboratory activities compliance to company policy & CGMP/CGLP regulations and documenting the observations & necessary actions in "Lab QA Observation Sheet" 4. Reviewing of laboratory analytical reports received from quality control along with specification/SOP 5. Monitoring & ensuring usage of valid chemicals & reagents, valid laboratory standards, valid media used for microbiological testing, correct test methods, caliberated & certified instruments/equipments, operation by competent trained & certifie...

Responsible for overall administration and oversight of quality control, quality assurance, and quality improvements at testing laboratory Quality Assurance Laboratory Professionals ( LAB QA) Develop and implement quality assurance protocols, Lead teams in addressing quality-related issues Bachelor degree in Medical Laboratory Technician / M. Sc

Quality Assurance & Control: Maintain quality management systems (QMS) in compliance with ISO 9001, BRC, GMP, or other relevant industry standards . Monitor and enforce quality control processes throughout the manufacturing cycle, from raw materials to finished goods. Conduct regular inspections, audits, and quality checks on production lines to ensure adherence to specifications. Establish quality KPIs (e.g., defect rates, customer complaints, process capability) and ensure continuous improvement in product quality. Lead root cause analysis (RCA) and corrective/preventive action (CAPA) for quality issues, working closely with cross-functional teams. Supplier & Customer Quality Management: C...

Adherence to Good Laboratory Practices (GLP) and Standard Operating Procedures (SOPs). Support internal audits of laboratory processes and documentation. Ensure proper documentation and traceability of samples, reagents, and instruments. Help maintain calibration and validation records of lab equipment.

Key Responsibilities: Manage all Analytical Quality Assurance (AQA) activities. Review, approve, and close Quality Management System documents related to QC. Act as Single Point of Contact (SPOC) for submission activities Dossier, Regulatory, Variation filings. Handle customer communications related to QA. Review manufacturing, packing, analytical reports of submission/validation batches. Review Stability data and ensure submission compliance. Ensure compliance of Stability Studies and Control Sample Handling at site. Ensure adherence to GDP/GLP. Monitor compliance of Gowning/De-gowning in QC lab. Authorize written procedures, amendments, and related documentation. Ensure SOP compliance acro...

Preferred candidate profile Candidate must be from API/Bulk Drugs/ Chemical Industry. Role & responsibilities Quality System Management: Develop, implement, and maintain quality assurance policies and procedures in line with cGMP, ISO, and other relevant regulatory standards. Team Leadership & Mentoring: Lead, manage, and train the QA team, fostering a culture of quality and continuous improvement. Process & Product Quality: Oversee quality testing activities, analyze quality trends, identify non-conformities, and ensure the final API product meets high-quality standards. Supplier Quality Management: Provide Quality oversight of external vendors, assess supplier qualifications, and manage AP...

Develop and implement a strategic vision for the QA function aligned with the company's overall business goals. Provide leadership and direction to the QA team, ensuring a consistent and integrated approach to quality management. Develop, implement, manage, audit and maintain GMP quality systems. Coordinate and perform all vendor qualification and compliance Should have well versed with handling of Regulatory Audits, APQR, OOS, OOT, Investigation, Laboratory Compliances, HVAC & Water Qualification & Validation, IPQA, Lab QA, Validation & Qualification and QMS. Develop, manage and maintain a GMP compliant document control system. Oversee investigations of all non-conformances (deviations, err...

Role & responsibilities Review of batch manufacturing record, analytical raw data, certificate of analysis, and conformity of compliance. Review of QMS documents like CAPA, Change control, Deviation, Investigation, OOS, OOT, Lab Incident, Events, Oversight observations. Risk Assessment, trending and Audit related Activities. Coordination with Contract manufacturing organization team and Alembic internal team for QMS related activities like change control, Deviation, OOS, OOT, lab Incident etc. Review stability protocol, Stability Data Review-Protocols, Summary Sheet. Preparation and review of SOPs and Quality agreements. Management of vendor qualification and relevant documents review. Inves...

Conduct routine,non-routine analyses of in-process materials, raw materials, packaging material,water samples, finished goods, stability samples.Interpret test results, compare them to established specifications control limits, make recommendations Required Candidate profile Perform visual inspections of finished products/raw material/packaging materialVerify accuracy,completeness laboratory test data, perform appropriate analyses Calibrate, validate,maintain laborator.

Responsible for detailed review of Finished Products, In-Process, Raw material and Stability study analytical reports along with audit trail review of each analytical data. - Responsible for review of stability study protocols of annual batch or validation batch and ensure for charging of stability study sample. -Responsible for review of stability summary sheets of stability analytical data - Responsible for review routine monitoring data of stability chambers - Responsible for review of laboratory incidents investigations and its closure. - To comprehensively review the audit trail logs of laboratory software - To ensure the overall compliance level of laboratory as per guidelines and stan...

Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on ...

As a member of our team, you will be responsible for ensuring data integrity within the laboratory by implementing quality management systems, conducting internal audits, and ensuring compliance with regulatory standards. Your primary focus will be on maintaining the accuracy, reliability, and security of all data generated in the laboratory. In this role, you will work closely with various stakeholders to establish and maintain quality assurance processes that support the overall quality management system. You will also be responsible for identifying areas for improvement and implementing corrective and preventive actions to address any non-conformances. A key aspect of your role will be to...

Excellent job opportunity for QA - AQA Specialist in Unison Pharmaceuticals Pvt Ltd, Moraiya, Ahmedabad About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry. You are invited to join one of India's fastest growing pharma companies in India!! Experie...

Role & responsibilities To support R&D Executives for all activities as directed • maintain cleanliness of testing equipment • Support chemist in maintaining the records at stipulated & confined area • Provide samples for Testing of incoming RM from trucks Take samples as per given directives from QC chemists • Provide production samples for lab testing • Maintain General Housekeeping of QC Support ISO documentation and filing. 5s, kaizen

Role & responsibilities In-depth knowledge of microbial techniques such as sterility testing, BET, Preservative Efficacy Test, Microbial Limit Test, Culture Identification, Growth Promotion Test, and Environmental Monitoring programs. Proficient in soft skills and tools including MS Word, Excel, PowerPoint, LIMS, and MINITAB. Skilled in trend data analysis using MS Excel, including histogram plotting, use of formulas, hyperlinks, and other advanced functions. Excellent written and verbal communication skills in English. Experienced in regulatory audits and interactions with inspectors as an SME for agencies such as US-FDA, MHRA, TGA, EU-GMP, ANVISA, Ukraine, and PIC/S. Preferred candidate pr...

Role & responsibilities Roles and Responsibilities 1. Stability study documents compilation and its management. 2. Stability charging, withdrawal, trend and stability report preparation. 3. Review of DRS, Log book entry and related documentation to be make online. 4. Preparation of release COA and compilation of all related documents. 5. Provide training to new person or existing person for QC testing. 6. Preparation and review of Specification/STP/SOP/DRS/protocol/data recording sheet for QC documentation on routine basis. 7. Instrument and Equipment calibration activity. 8. QMS (change control/deviation/Incident/LIR etc.) related Activities. Desired Candidate Profile -Male Candidate Requir...