The role involves assisting the Manager Chemical in the Raw Material section of the Quality Control (QC) Laboratory, ensuring smooth operations and adherence to quality standards. The candidate will support various activities related to raw materials, including testing, documentation, and compliance, while maintaining high standards of Good Manufacturing Practices (GMP), current GMP (cGMP), and current Good Laboratory Practices (cGLP). This position requires close collaboration with multiple departments to ensure timely completion of tasks and readiness for audits and inspections.
Key Responsibilities
- Ensure all activities within the Raw Material section comply with quality standards and do not compromise GMP, cGMP, or cGLP requirements.
- Support the Manager Chemical in setting, reviewing, and achieving annual goals related to the Raw Material section.
- Assist in maintaining timely Key Performance Indicators (KPIs) to meet supply plans and avoid delays.
- Collaborate with the MIS department to resolve issues related to instrument systems and individual PC systems.
- Support qualification activities related to equipment and system compliance within the QC Lab.
- Manage daily labeling of distilled water on water bottles, carboys, and eye wash bottles in the Raw Material section.
- Assist the Manager Chemical with SOP writing, equipment handling, and other assigned tasks.
- Provide timely support for testing vendor trial samples and project-related testing.
- Perform routine water testing and validation of water samples, ensuring complete and accurate documentation.
- Ensure on-time completion of monthly and ISO-related trainings or any additional training required throughout the year.
- Support the Quality Control Manager (QCM), Manager Chemical, and EHS Coordinator in Environmental, Health, and Safety (EHS) inspection readiness within the QC Lab.
Required Qualifications
- Master’s degree in Chemistry (M.Sc.), Pharm-D, or Bachelor of Pharmacy (B.Pharm).
- 1 to 2 years of relevant experience in a similar role within Quality Control or Quality Assurance.
- Strong knowledge of technical problem resolution and familiarity with QC/QA laboratory activities.
- Understanding of GMP, cGMP, and cGLP standards and their application in a pharmaceutical environment.
Preferred Qualifications and Benefits
- Experience in supporting audit inspections and EHS compliance activities is highly desirable.
- Ability to work collaboratively across departments to ensure operational efficiency and compliance.
- Exposure to equipment qualification and system compliance processes.
- Opportunity to contribute to continuous improvement initiatives within the QC Lab.
This position is part of the Operations Quality job family within the Established Pharma Division. The role is based in Karachi, Pakistan, with a standard work shift. Travel requirements and medical surveillance are not specified for this position. The base pay may vary depending on the location.
The successful candidate will play a vital role in maintaining the integrity and quality of raw materials, ensuring that all laboratory activities align with regulatory and company standards. This position offers the chance to develop expertise in quality control processes within a dynamic pharmaceutical environment.