279 Glp Jobs - Page 12

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Under supervision of reporting manager developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applying the assay for the analysis of drugs and metabolites in biological fluids. Job Responsibilities Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre s, Standard Operating Procedures and in a consistent manner with current regulatory (DCGI- CDSCO, TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations. To work with the assigned project lead for Bioanalytical method development, Bioanalyitcal Method validation and Routine batch sample analysis (RBSA). Involves in preparation of project specific solutions and sample preparation. Documents all the work and results of all assignments as required. Verifies and saves acquired results in Chromatography Data acquisition systems, when required. Performs Laboratory Investigation, when required. Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems. Performs raw data compilation, assists in project wrap-up. To ensure lab work area cleanliness. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Minimum Bachelor Degree holder in Pharmacy or Masters Degree in Science. Knowledge, Skills and Abilities Good knowledge of GLP requirements. Good skills in MS Office. Good in Communication skills. Flexible to work Strives to drive projects related to Bioanalytical effectively. Experience Minimum 2-4 years of experience in Bioanalytical. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Responsible for day-to-day activities of Quality Control, prepare and maintain documentation as per cGMP norms. Working Experience on HPLC is must Coordinate with other depart for smooth running of plant Capable of handling external Audits Required Candidate profile Min Exp 2 to 10 years in Quality department of a reputed pharmaceutical Company Knowledge of working in GMP Co. MS Office (MS Word & MS Excel) / ERP software. and good time management skills Perks and benefits Performance linked incentive & annual bonus extra

1. Laboratory Quality Compliance: Ensure QC laboratory operations comply with GLP, GMP, and global regulatory standards. Implement and maintain laboratory quality systems, including data integrity controls and documentation practices. Review and approve laboratory investigations, Out-of-Specification (OOS) and Out-of-Trend (OOT) reports, and Corrective and Preventive Actions (CAPA). 2. Regulatory & Audit Compliance: Prepare and participate in regulatory inspections (USFDA, MHRA, WHO-GMP, etc.), customer audits, and internal audits. Ensure timely implementation of audit observations and compliance commitments. Maintain compliance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) principles for data integrity. 3. Documentation & SOP Management: Develop, review, and approve Standard Operating Procedures (SOPs) related to laboratory quality assurance. Oversee the review and approval of analytical reports, Certificates of Analysis (CoAs), and method validation protocols. Ensure proper documentation control and record-keeping for all QC lab activities. 4. Laboratory Investigations & Risk Management: Lead investigations related to laboratory deviations, instrument failures, and non-conformities. Identify root causes and implement corrective and preventive actions (CAPA). Monitor laboratory trends to proactively mitigate risks affecting product quality. 5. Training & Continuous Improvement: Conduct training sessions on GMP, GLP, data integrity, and regulatory updates for QC and QA personnel. Promote continuous improvement initiatives to enhance lab efficiency and compliance. Stay updated on changes in pharmaceutical regulations and implement necessary changes in lab QA practices. 6. Instrument Qualification & Method Validation: Oversee qualification and calibration of analytical instruments (HPLC, GC, FTIR, UV, etc.). Ensure compliance with method validation, verification, and transfer protocols. Collaborate with QC teams to ensure analytical methods are robust and compliant.

Process Development: Contributing to the development of scalable processes for API Manufacturing. You may work on process optimization to improve yield, selectivity, and purity of the target molecules. Laboratory Work: Conducting hands-on experiments in the laboratory to synthesize and analyze API samples. You will be familiar with various laboratory techniques, such as organic synthesis, purification, and analytical methods Problem-Solving and Troubleshooting: Identifying and troubleshooting issues that arise during API synthesis or analysis and proposing effective solutions. Analytical Characterization: Analyzing and characterizing API samples using techniques such as HPLC, GC, NMR, and IR spectroscopy. You will be responsible for interpreting analytical data and ensuring the quality and consistency of the APIs. Data Analysis and Documentation: Recording experimental data accurately and maintaining comprehensive lab notebooks. You will also be involved in writing technical reports and documentation related to your research and development work. Regulatory Compliance: Adhering to relevant regulatory guidelines and ensuring that API Development activities are conducted in compliance with Good Laboratory Practice (GLP) and other regulatory requirements. Safety and Environmental Practices: Following proper safety protocols in the laboratory and adhering to environmental practices to minimize the impact of chemical processes.