Quality Management System Specialist

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