Our client, A leading Biotechnology company is looking to engage with consultant who can deliver the following responsibilities:
- Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice).
- To collect samples and to carry out all tests and to issue test reports as per documented procedures.
- In process, Finished product, validation, stability samples inspection, testing and reviewing.
- Corrective and preventive actions as and where applicable
- Preparation / Review and maintenance of Quality of the records.
- Preparation /Review of product specifications and analytical Record.
- Preparation and review of certificate of analysis.
- Training of personnel.
- Issue and review of log sheets/Annexures/Raw data books/Checklist/log sheets for record times.
- Handling of SAP related activities like Creation of Inspection plan, uploading of results.
- Handling and Investigation of OOS, OOT, OOC, Deviation and Incidents.
- Product Traceability, Visual inspection and Destruction of Reserve samples.
- Qualification and requalification of Analytical instruments/Cooling Chambers/Rooms.
- Preparation and Review of Analytical method validation, Method transfer and temperature mapping protocols and reports.
Qualification
- :Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Life Sciences, or a related scientific discipline
- .Minimum 5–8 years of experience in Quality Control, Analytical Laboratory, or Quality Assurance functions within the pharmaceutical, medical device, or regulated manufacturing industry
- .Strong knowledge of cGMP, cGLP, GDP, and applicable regulatory requirements, including documentation and data integrity practices
- .Hands-on experience in testing and review of raw materials, in-process samples, finished products, validation samples, and stability samples
- .Proven experience in handling and investigating OOS, OOT, OOC, deviations, incidents, and CAPA activities
- .Expertise in preparation, review, and maintenance of analytical records, product specifications, Certificates of Analysis (CoA), protocols, and quality documentation
- .Experience in analytical method validation, method transfer studies, temperature mapping, and qualification/requalification of laboratory instruments and storage facilities
- .Working knowledge of SAP Quality Management (QM) module, including inspection plan creation, result recording, and quality data management
- .Strong analytical, problem-solving, documentation, and investigation skills with the ability to identify root causes and implement effective corrective actions
- .Excellent communication, training, and stakeholder management skills, with the ability to work collaboratively in a cross-functional and compliance-driven environment
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