Job Description 1. POSITION SUMMARY: - The Quality Management System (QMS) Specialist is responsible for fostering a continually improving quality culture . The QMS Specialist is responsible for ensuring compliance, effectiveness, and operational excellence. The QMS Specialist provides support for areas such as change control management, corrective and preventative actions/non-conformance investigations, customer complaints and GMP/FDA audits. Leads quality process improvement in process validation, annual product reviews, vendor quality management systems, raw material assurance, risk assessments and data integrity projects. 2. THE ROLE: - Providing Quality leadership to execute GMP/US FDA standards - Identifying and leading Quality improvement projects supporting the Quality and Operations groups - Drafting, reviewing and approving QMS records after conducting scientifically sound and logical investigations. - Analyzing quality and process work, and recommending efficiency improvements in process validation/stability studies/standard operating procedures - Supporting other QA functions including Management Review and customer, internal and third-party audits - Participating in the site's GMP/US FDA and Internal audit program - Working with site quality leadership and Regulatory team to identify root cause and facilitate effective corrective action for findings - Tracking and trending Quality data. Identifying and developing actionable Quality Metrics. Building and maintaining strong APQR matrix and support Regulatory team to submit the annual reviews. - Driving continuous improvement of established Quality systems. Contributing to the development of relevant regulatory standards - Nurturing positive working relationships with internal and external teams to meet the responsibilities of the position - Establishing an effective change management system and ensuring all changes in the QMS are recorded with updated change order log - Training others in root cause investigation techniques. 3. THE CANDIDATE: Mandatory requirements: - Degree in Science/Pharmacy/Technology (i.e., Pharmacy, Engineering, Chemistry, Microbiology, other related fields) from a top-tier college - 8-15 years working experience in Quality with pharmaceutical ingredients, excipients, or products - Preferably has working experience in a US FDA approved facilities - Solid exposure in Quality systems within pharma formulations/finished product industry with US FDA exposure - Experience with US FDA/GMP audits is preferred - Must have experience in incidence analysis, root cause analysis , framing CAPA. - IPEC-PQG GMP training/exposure and/or ICH/ USFDA/MHRA/ PICs /EXCiPACT training. - Excellent oral, written, and communication skills. - Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point, Minitab and flowcharting software. Essential behaviors and skills: - Ability to evaluate and prioritize position responsibilities to meet established timelines. - Ability to establish/handle and maintain the change control management systems - Efficient in handling Quality complaints and take necessary quality actions to update the system - Collaborate with plant quality team to help them drive QMS - Ability to support the wider organization to meet global regulatory quality requirements - Ability to train the plant quality teams by advising on productivity, adequate compliance including the good manufacturing practices

Hyderabad

Quality Management System Specialist 

Job Description for Quality Management System Specialist  in Vigna World in  Hyderabad for (8-15) years of experience. Apply Now!