SUMMARY/OBJECTIVE
This position supports activities of the Quality Assurance Department regarding pharmaceutical manufacturing, testing and packaging to ensure compliance with all relevant pharmaceutical regulatory requirements: FDA, GMP. Provides QA oversight to operations under direction of the QA Manager. Provides review, impact/risk assessment analysis, detailed improvement plans for change controls, deviations, investigations and CAPA. Adheres to Tedor Pharma compliance initiatives, including
following all quality and division/company policy requirements. Helps to ensure that all Tedor Pharma products meet quality requirements by supporting all assigned quality aspects of product approval. The
QA Associate II/III independently conducts quality assurance audits of production records (manufacturing, analytical and quality control records) and facility records assuring company standards are maintained and product integrity is preserved.
RESPONSIBILITIES
1. Provide support to GMP investigations, validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management;
2. Participates/leads internal/external audits, prepare and issue audit reports. Recommend remediation actions and follow up on implementation of the plan.
3. Supports resolution of technical and compliance issues/gap analysis.
4. Aides implementation of Quality Systems/System Improvements.
5. Supports and assists with Quality systems-related training, including compliance with cGMP and SOPs.
6. Interface with key quality, manufacturing, customers and coordinate documentation impacting quality areas.
7. Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control, deviation & document revisions, etc.
8. Participates in activities associated with primary batch record review, non-conformances investigation and CAPA.
9. Work in coordination with regulatory affairs group in support of ANDA submissions.
10. Provides QA review/approval of all cGMP documents associated with manufacture of product.
11. Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
12. Authors or revises SOPs as necessary.
13. Actively engaged in the training of staff with lesser experience or knowledge of quality assurance processes. Educate and instruct QA and plant personnel in quality best practices for sampling, labeling,
good documentation practices, equipment sanitation. Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed.
14. Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
15. Assist in development of special department projects and work in conjunction with quality management.
16. Other duties as assigned.
COMPETENCIES
1. Project Management
2. Technical Capacity.
3. Discretion.
4. Problem Solving/Analysis.
5. Decision Making.
6. Communication Proficiency.
7. Collaboration Skills.
8. Learning Agility
9. Managing Changing Priorities
POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time position requiring 40 or more hours of work per week.
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