Manager - Quality Control - Manufacturing Firm

Role Objective:

- A key objective of this role is to oversee and ensure the implementation of Good Practices within the Quality Control Department.

- They will be responsible for maintaining standard operating procedures (SOPs), conducting testing in adherence to written procedures and managing the analysis of various samples.

- Additionally, they will play a crucial role in method validation, calibration of instruments, training of personnel, and ensuring compliance with regulatory standards.

Role Requirements:

Good Practices Maintenance:

- Ensure adherence to Good Practices in the Quality Control (QC) department.

Standard Operating Procedures (SOPs):

- Develop, implement, and follow SOPs in the QC department.

- Ensure all testing procedures comply with written protocols or compendial methods.

Sample Management:

- Plan and manage the daily analysis of samples, including raw materials, packaging materials, finished products, intermediates, in-process samples, stability samples, and routine analysis.

- Perform sampling, analysis, and report results as required.

- Oversee the proper destruction of leftover samples post-analysis.

Analytical Methodology:

- Conduct Analytical Method Transfer (AMT) and Analytical Method Validation & Verification (AMV) as needed.

- Prepare and maintain working standards, reference standards, and ensure their qualification.

System Registration and Reporting:

- Ensure timely registration of samples in the system and prepare monthly reports.

- Record raw data and analytical results accurately in analytical logs.

Training and Compliance:

- Provide on-the-job training to new QC team members.

- Ensure lab incidents, out-of-specification (OOS) results, out-of-trend (OOT) events, and any deviations are reported and logged for further investigation.

Instrument Calibration and Maintenance:

- Ensure all lab instruments are calibrated before their due dates.

- Prepare and review master calibration and preventive maintenance plans, as well as training schedules.

Stability Studies:

- Prepare and review Stability Study Protocols, Hold Time Study Protocols, and Qualification Protocols as per defined procedures.

- Manage stability chambers, sample loading, and analyze stability and hold time study samples.

- Prepare stability summary reports.

Quality Assurance:

- Review and ensure the adequacy and integrity of analytical and raw data.

- Establish systems for the release or rejection of raw materials, intermediates, and packaging materials.

Software and System Qualifications:

- Ensure all software and applications used in the QC department are qualified.

- Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

- Perform Audit Trail Reviews in the system.

Functional Skills:

- Thorough knowledge of analytical instrumentation.

- Comprehensive understanding of Good Manufacturing Practices (GMP).

- Proficiency in method validation and analytical techniques.

- Strong organizational and planning skills.

- Excellent written, verbal, and interpersonal communication skills.

- Demonstrated ability to work independently and efficiently manage multiple deadlines.

Behavioral Skills Required:

- Strong problem-solving abilities.

- Effective leadership and team management skills.

- Attention to detail and accuracy in work.

- Adaptability to changing priorities and environments.

- Commitment to quality and compliance standards