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Quality Management System Specialist
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Abryl Laboratories
Job Description
Company Description Abryl Laboratories is a state-of-the-art manufacturing facility specializing in sterile liquid and lyophilized products, as well as pre-filled syringes. Established in 2016, the company is driven by a mission to deliver high-quality pharmaceutical products to global markets. With the capacity to manufacture over 60 million liquid vials and ampoules annually, Abryl leverages advanced technologies and robust processes. The facility operates in strict compliance with USFDA and other leading international regulatory standards, offering team members the opportunity to work in a highly regulated, quality-focused environment.
Role Description The Quality Management System Specialist is a full-time, on-site role based in Dera Bassi. This position is responsible for maintaining and improving the quality management system, including developing, reviewing, and updating SOPs and documentation to ensure regulatory compliance. Day-to-day tasks include monitoring quality processes, supporting internal and external audits, coordinating corrective and preventive actions (CAPA), and ensuring alignment with USFDA and other regulatory requirements. The specialist will collaborate with production, quality control, and quality assurance teams to identify process improvements, analyze deviations, and promote a culture of continuous quality enhancement. The role also involves preparing quality reports, training team members on QMS procedures, and supporting validation and qualification activities as needed.
Qualifications
Role Description The Quality Management System Specialist is a full-time, on-site role based in Dera Bassi. This position is responsible for maintaining and improving the quality management system, including developing, reviewing, and updating SOPs and documentation to ensure regulatory compliance. Day-to-day tasks include monitoring quality processes, supporting internal and external audits, coordinating corrective and preventive actions (CAPA), and ensuring alignment with USFDA and other regulatory requirements. The specialist will collaborate with production, quality control, and quality assurance teams to identify process improvements, analyze deviations, and promote a culture of continuous quality enhancement. The role also involves preparing quality reports, training team members on QMS procedures, and supporting validation and qualification activities as needed.
Qualifications
- Candidates should possess strong Quality Management and Quality Assurance skills, with experience in implementing and maintaining QMS in a regulated manufacturing environment.
- Candidates should possess solid Quality Control skills, including familiarity with testing protocols, documentation standards, and compliance monitoring.
- Candidates should possess robust Analytical Skills to assess data, investigate deviations, and support root cause analysis and CAPA activities.
- Candidates should possess effective Communication skills for collaborating with cross-functional teams, preparing reports, and supporting audits and regulatory inspections.
- Relevant experience in sterile pharmaceutical manufacturing and knowledge of USFDA or similar regulatory guidelines is highly beneficial.
- A bachelor’s degree in pharmacy, chemistry, biotechnology, engineering, or a related scientific field is preferred.
- Strong attention to detail, organizational abilities, and proficiency with standard office and documentation software are advantageous.
- Ability to work on-site in Dera Bassi and contribute to a culture of safety, quality, and continuous improvement.
Required Skills
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