Director, Manufacturing Quality Assurance - Pharmaceuticals
|Monroe, North Carolina - United States
$140,000.00 - $150,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
The Director, Manufacturing Quality Assurance directs a team of In-Process Quality Assurance (IPQA) staff across multiple shifts to oversee all quality aspects of pharmaceutical manufacturing for a facility that manufactures both sterile and oral solid dose products. This oversight includes, but is not limited to: warehousing, dispensing, manufacturing, packaging, and calibration. The IPQA team provides immediate direction for potential quality issues on the shop floor, including first assessment of potential deviations and initial determination of product impact and immediate corrective actions, including the management of product, equipment and system/facility holds. The Director is responsible for providing Quality Assurance oversight in the production process, ensuring that products, materials, batch records and labeling are properly managed according to cGMPs and other internal and external regulations and standards. The Director is responsible to maintain a Quality Assurance presence on the site floor and partner with Area Management to drive the Quality culture and mindset at the site. The Director is also responsible for overseeing batch review and disposition for both commercial and development projects.
- Preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site
- Maintain quality system controls to ensure no critical and major market complaints
- Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable
- Take appropriate steps to reduce waste and losses in the analysis process and build improved efficiency
- Provides leadership, mentoring and development opportunities for the IPQA staff
- Ensures IPQA are appropriately trained and aligned to support plant operations
- Align with site goals and ensures IPQA staff is supporting Quality, Compliance and Production objectives, focused on Quality Throughput
- Provides Strategic direction to the In-Process QA group in alignment with site and QA objectives, to ensure that business and compliance needs are met
- Ensure the IPQA staff is available and active in first response to product quality issues for all shifts
- Ensures product, facility, and equipment holds are placed when batch, equipment or systems are potentially impacted
- Provide Line clearance in every step of manufacturing prior to commencement of manufacturing and during change over
- Ensure the materials are dispensed as per the standard quantities mentioned in the batch manufacturing record
- Perform online checking of in-process parameters
- Ensure in-process sampling of finished Product, stability and retention samples for the development, commercial and validation batches
- Ensure online review / checking of batch manufacturing and batch packaging records
- Ensure the process is being manufactured as per the batch records
- Monitor all shop floor activities.
- Monitor cleaning and sanitation procedures
- Ensure manufacturing areas and their premises are maintained as per cGMP
- Responsible for overall management of IPQA activities
- Responsible for coordination with Production/R&D/QA/QC for various activities
- Ensure GMP compliance at shop floor as per respective SOP’s
- Compliance verification of SOP’s of QA/Production/Warehouse
- Ensure the timely review of executed batch records
- Review of in process testing and executed batch production record
- Preparation, review and approval of sampling matrix and hold time schedule
- Ensure that all equipment is calibrated.
- Training of all the IPQA staff
- Able to lead and develop QA Team
- Able to represent department during internal and external audits and inspections
- Lead the process for batch review and disposition
- Consult, review and approve quality event management records
- A minimum of a Bachelor’s degree in Science or Engineering or associated fields is required.
- A minimum of 10-15 years or more experience in Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, or medical device industry (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing.
- Advanced degrees may be used to reduce required experience.
- Demonstrated experience working with sterile dosage forms in a sterile manufacturing environment.
- Experience with pre-filled syringes, blow-fill seal technology is a plus.
- Extensive knowledge of quality tools:
- Validations and Qualifications
- Regulatory guidelines
- US Pharmacopoeias
- Internal auditing
- Handling of regulatory Inspections
- Well acquainted with QMS
- Well versed with Change control/deviations and market compliant management system.
- Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (QDP); and ICH Q8, Q8, and Q10 procedures.
- Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) strongly desired
- Proficiency with Microsoft Word, Microsoft Excel, and Power Point is required. Strong documentation skills are required. Experience with comparative Statistical techniques, sampling plans, GR&R, hypothesis testing, ANOVA, parametric and non-parametric analysis are also desired.
- The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication and interpersonal relationship skills
- Will be an added advantage if the individual has dealt with multiple audits personally.
University - Bachelor's Degree/3-4 Year Degree