In the fast-paced world of pharmaceuticals and manufacturing, the role of a Senior Officer in Quality Assurance (QA) is crucial. This position not only ensures the integrity of products being manufactured but also guarantees compliance with stringent regulatory standards. If you are passionate about maintaining high-quality standards and have the relevant experience, this role could be the perfect fit for you.
Key Responsibilities
1. Documentation & Compliance
One of the primary responsibilities of a Senior Officer in Quality Assurance is to manage documentation and ensure compliance with both regulatory and internal quality standards. Key tasks in this area include:
- Preparing and Maintaining Production Records: This includes creating and updating Standard Operating Procedures (SOPs), logbooks, and other essential documents required for production processes.
- Ensuring Accuracy and Up-to-date Information: The Senior Officer must ensure that all documentation is precise, relevant, and aligned with quality standards.
2. Commercial Batch Manufacturing
Overseeing the commercial batch production process is another significant responsibility. This involves:
- Monitoring Adherence to Batch Records: Ensuring strict compliance with Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Conducting In-Process Quality Checks (IPQC): Regular quality checks need to be performed during the production process, adhering to the guidelines set forth in BMR/BPR.
- Workflow Oversight: Cross-checking workflow, ensuring accurate material labeling and quantity checks as specified in BMR/BPR.
- Sanitation and Maintenance: Ensuring the production area is well-maintained and sanitized, complying with good manufacturing practices (GMP) and SOPs.
3. Workplace Environment & Safety
Safety in the workplace is paramount. The Senior Officer plays an essential role in maintaining a safe work environment by:
- Implementing 5S Methodology: Ensuring that the 5S methodology is integrated into batch trials to promote a clean and organized workspace.
- Promoting Workplace Discipline: Ensuring adherence to safety protocols and general workplace discipline is maintained.
- Knowledge of Emergency Procedures: Possessing a basic understanding of first aid and emergency protocols to react swiftly when needed.
- Reporting Safety Concerns: Communicating any equipment malfunctions or other safety-related issues to supervisors.
4. Record Maintenance & Reporting
Maintaining accurate records is fundamental in QA. Responsibilities include:
- Daily Activity Records: Oversight of daily activities and accountability of junior staff members.
- Timeliness and Accuracy of Documentation: Ensuring that BMR/BPR documentation is completed accurately and on time.
- Batch Labeling and Log Maintenance: Supervision of batch labeling and the maintenance of production logbooks.
- Calibration Record Management: Keeping an updated record of calibration for all production instruments.
Job Specification
Professional Competencies
To be successful in this role, candidates are expected to possess the following qualifications:
- Educational Background: A Bachelor’s degree in Pharmacy, Chemistry, or a related field.
- Relevant Experience: 2-3 years of experience in Quality Assurance within a pharmaceutical or manufacturing setting.
- Knowledge of Quality Standards: A solid understanding of GMP, SOPs, and regulatory compliance processes.
- Attention to Detail: Exceptional organizational skills and a keen eye for detail are essential to uphold product quality.
- Team Collaboration: Ability to work effectively within cross-functional teams.
Behavioral Competencies
Alongside technical skills, the following behavioral traits are equally important:
- Integrity: Building trust through authentic communication and actions.
- Courage and Confidence: Standing firm in decision-making processes, managing uncertainty professionally.
- Flexibility: Adaptability to changing environments and workloads.
- Strong Work Ethic: Commitment to working hard while effectively prioritizing tasks.
Why Join Us?
The position of Senior Officer in Quality Assurance is not just a job—it’s a critical role in maintaining product quality and ensuring regulatory compliance in a dynamic industry. If you are driven by a passion for quality and possess the relevant skills, we invite you to APPLY NOW and become a part of our commitment to excellence in manufacturing and safety standards.
