Manager, QA Operations

Hercon Pharmaceuticals is dedicated to the manufacturing and development of generic transdermal medications. Managed by Cadila Healthcare, a fully integrated global healthcare provider with over 20,0000 employees, we have an opportunity available in our Pharmaceutical Transdermal Manufacturing Facility located in York, PA.

The Manager, QA Operations is responsible for activities pertaining to assurance of product quality and compliance to regulatory requirements in the manufacture, testing, release, and distribution of pharmaceutical clinical and commercial products.

E ducational Qualifications:

• BS in scientific field (chemistry, engineering, etc).

Required Experience:

• 7-10 years' experience in a cGMP pharmaceutical manufacturing environment with focus on quality assurance and supervisory experience
• Strong organizational skills, possess excellent communication skills and strict attention to detail
• Strong 21CFR211 background with an ability to implement pragmatic solutions to ensure cGMP compliance

Essential Functions/Responsibilities:

• Provides guidance, training, coaching and work assignments for QA operational staff.
• Coordinates interdepartmental activities with QC, Supply Chain and Operations to meet business requirement.
• Provide expertise knowledge to operations to resolve floor issues or implement corrections.
• Performs administrative duties with respect to compliance activities including, but not limited to Med Watch reporting and the Annual Report
• Responsible for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product
• Reviews and authorizes batch production records and quality control documentation and dispositions executed batches
• Responsible for FDA interaction or other customers and documenting outcome of FDA investigations
• Sets-up and tracks material flow and material-labeling process to ensure compliance with cGMP program.
• Resolution of quality issues and deviation investigation, including verification of CAPA and follow up actions
• Perform quality trends analysis and reports, recommending continual improvements opportunities
• Inform management of critical QA discrepancies and provide timely impact assessments of potentially affected products, materials or processes

We offer a competitive salary and benefits package.

Current Openings for Manager, QA Operations Jobs at Zydus Pharmaceuticals