What are the responsibilities and job description for the Group Lead, Batch Record Review position at Medvacon Life Sciences?
The Quality Assurance (QA) Group Lead Batch Record Review is responsible for overseeing a group of Batch Record Reviewers preparing the technical and final release of our products.
The QA Batch Record Reviewer performs functions necessary to ensure that all relevant manufacturing records are compiled, reviewed and completed in a compliant and efficient manner. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and company Standard Requirement Documents. This position requires attention to detail and must be performed in accordance with standard operating procedures and all applicable regulatory and GMP requirements.
The QA Batch Record Reviewer performs functions necessary to ensure that all relevant manufacturing records are compiled, reviewed and completed in a compliant and efficient manner. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and company Standard Requirement Documents. This position requires attention to detail and must be performed in accordance with standard operating procedures and all applicable regulatory and GMP requirements.
Key Responsibilities:
Responsible for meeting assigned goals in technical and final release review including, but not limited to:- Leading a team of consultants performing Batch Record Review including holding them accountable for the work and motivating them to keep spirits up.
- Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Providing consultation or advice in alignment with QA policies
- Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk
- Reviewing, editing, or approving controlled documents
- Reviewing and approving of investigations associated with raw materials, product, laboratory, facilities, and materials
- Performing status labeling of raw materials and product
- Continually evaluating processes and procedures with an eye toward continuous improvement
- Supervising direct reports
- Performs other duties as assigned by the line management
Required Background and Experience:
- Minimum of six years' experience in quality assurance and GMP in the pharmaceutical / biotech industry is preferred
- Minimum Bachelor degree in a scientific discipline (e.g. pharmacy, chemistry, engineering, life science) or similar education; advanced degree in natural or applied sciences preferred
- Have previous leadership/supervisory experience
- Excel in a quality driven organization
- Have an understanding of biologics manufacturing operations
- Are organized and have an attention to detail
- Can prioritize multiple assignments and changing priorities
- Are able to learn and utilize computerized systems for daily performance of tasks
Required Competencies:
- Ability to work with tight deadlines as well as strong planning, organizing and time management skills
- Attention to details, dedication to accuracy
- Reliable and with high sense of accountability
- Ability to work independently
- Strong problem solving and analytical skills
- Reliable team-player with strong competence in leading cross-functional teams and operating within a matrix organizational structure
- Strong verbal and written communication skills
