Quality Control Manager
|Monroe, North Carolina - United States
$75,000.00 - $125,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Quality Control Manager to join our growing team. The Quality Control Manager is a highly organized member of Lab at manufacturing facility, reporting to the Senior Manager of QC. They are charged with maintaining compliance to cGMP in line with standards prescribed by USFDA. Ensuring compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA. Contributing and managing the set up of the QC lab at with guidance of CQA. Assisting in the establishment & maintenance of procedures and systems for Raw Materials (RM), Packaging Materials (PM), Finished Products (FP) and in process testing in QC lab. Responsible for evaluation and execution of stability study as per Quality and regulatory requirement. Manage the review and compliance during analytical TT and AMV performed in QC lab. Able to be a qualified trainer for QC related systems and SOP’s and responsible that personnel are appropriately trained.
Responsibilities include but are not limited to:
- Maintain the Revenue and Capex Budget as per spent analysis project manage
- Ensure there are adequate resources for planning, allocation, testing and manage within approved budgets for QC.
- Provide appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
- 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.
- Organize the day to day activities of the chemical testing laboratory which shall include in- process, RM, PM and FP samples, Swab sample and Tech Transfer (as applicable).
- Ensuring compliance to systems and procedures in finished product section.
- Evaluation of complaint sample (analytical part) and reporting the results to Associate Director.
- Prepare and/or review of Incidence & Out Of Specification (OOS) results.
- Maintain compliance in QC Laboratory for internal and external audits.
- To participate in interaction with Site QA and inform about failures / OOS / Non-compliance.
- Coordinate technology transfer of analytical methods for new products.
- To ensure the execution of cleaning validation of new products.
- To monitor changes in the monographs Pharmacopoeia requirements, Regulatory agencies recommendations and implement the same in QC Lab.
- Apply CAPA for Lab failures in OOS.
- Ensure availability of documentation for Regulatory filling.
- Ensure timely submission of completed report to documentation cell.
- Ensure timely updating and revision of SOP, specification, STP and any other documents
- Ensure timely completion of Tech Transfer of Finished products.
- Ensure training of QC staff
- Oversee the Tracking System Deployment for Stability Samples/ Process Validation Samples etc.
- B.Pharm/ B.Sc/ M.Pharm/ MS or equivalent
- Minimum of seven (7) years experience in the field of Pharmaceutical (formulation facility).
- Background of functions of Quality Control.
- Experience of R&D will be an added advantage
Knowledge & Skills:
- Demonstrated Knowledge of cGMP, 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.
- Capable to organize and maintain the QC team
- Good communications skills, front runner, cGMP trainer.
- Will be an added advantage if the individual has dealt with multiple audits personally.
University - Bachelor's Degree/3-4 Year Degree