Quality Assurance Specialist
3 weeks ago
Essential Qualification :
M.Pharm/ MSc./ MTech/Bsc./B.Pharm
Experience :
- 6-10 years experience quality assurance/ quality control with Candidature with solid dosage forms preferrable in herbal field with Juice processing or liquid orals formulation process who had responsibility for routine QA activities and to ensure GMP in the plant.
- Excellent communication and leadership skills
Job Summary & Responsibilities :
- Candidature with solid dosage forms preferrable in herbal field with Juice processing or liquid orals formulation process who had responsibility for routine QA activities and to ensure GMP in the plant.
- Responsible to monitor the quality products are produced and documentation is ensured for onlinity. Should have strong knowledge on the raw materials quality checks, in-process, equipment’s knowledge, FG release process, implementation of standards, documentation and approach to ensure defects free products.
- To ensure that actively involved in review of analytical data and to ensure that the sampling, coordinating with external lab. and release shall be effective with reporting of OOS, Deviations and incidents on needy basis.
- Capable of handling quality at site with complete controls over system enhancing quality standards, strong knowledge on vendor management, Packing materials, packing trials and reporting it in effective manner.
- Responsible to ensure that actively involve in process standardization, Optimization, regular batch monitoring and release of product.
- Responsible for effective implementation of quality assurance system in accordance with the company’s quality policies and procedures.
- To maintain high degree of discipline in daily working which are directly related to the quality of the product.
- To co-ordinate with site on water testing, equipment qualification, complaint management, implementing new system, coordinating with R & D and ensuring for smooth implementation.
- To review and approve technology transfer documents and ensuring the smooth commercialization and validation.
- To review and approve SMF/Quality Manual records.
- To instruct and guide all respective site QA Executives/Officers for strict implementation of quality assurance procedures.
- To work for constant up-gradation in the existing quality assurance systems through innovative ideas as per current regulatory guidelines
- To undertake quality review of systems, products and furnish quality audit reports to the management on annual basis
- Responsible to co-ordinate for continuous improvement programme
- To see periodically the quality assurance operations at the plant and create confidence in site quality assurance organization
- Responsible in devising schedule and execution of internal quality audit/self-inspection by identifying cross functional team. To review audit report and recommend action plan for the non-compliances
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