Manager, Quality Control

Job Description

Title: Manager, Quality Control

Company Name: Pristine Pharmaceuticals

Vacancy: 1

Age: At most 45 years

Job Location: Anywhere in Bangladesh

Salary: Negotiable

Experience:

• 10 to 12 years

• M. Pharm/B. Pharm or BSC/MSC in Chemistry (min CGPA 3.25).

• SSC and HSC (min CGPA 4.00).

• 10 to 12 years

• Age At most 45 years

• 10-12 Years of experience in a cGMP pharmaceutical manufacturing environment.

Pristine Pharmaceuticals is Looking for Smart, Energetic, Self-Driven and Career Conscious Candidates for the Following Positions.

Job Location:

Pristine Pharmaceuticals

5-7, 29 & 32 BSCIC Industrial Area, Mazgram

Patuakhali-8600, Bangladesh

Contact: +8801334761966

Email: [email protected]

Roles and Responsibilities:

In Pristine Pharmaceuticals, the Manager of Quality Control (QC) plays a crucial role in ensuring that the products manufactured meet the highest quality, safety, and efficacy standards. The manager oversees all quality testing activities and compliance with regulatory requirements. Below are the key roles and responsibilities:

Quality Control Oversight

• Supervise QC Operations: Manage and lead the Quality Control team, ensuring timely and accurate testing of raw materials, in-process samples, and finished products.
• Testing and Analysis: Oversee routine chemical, physical, and microbiological testing of pharmaceutical products.
• Laboratory Management: Ensure that the QC laboratory operates efficiently, maintains cleanliness, and is equipped with necessary instruments and reagents.

Compliance with Regulatory Standards

• Adherence to GMP: Ensure all quality control activities adhere to Good Manufacturing Practices (GMP), regulatory requirements, and company policies.
• Regulatory Audits: Prepare for and support internal and external audits, including those from the Directorate General of Drug Administration (DGDA), WHO, or other regulatory bodies.
• Documentation & Reporting: Ensure accurate and timely documentation of QC processes, testing results, deviations, and corrective actions.

Process Improvement & Quality Assurance

• SOP Development & Maintenance: Develop, update, and ensure adherence to Standard Operating Procedures (SOPs) for QC testing.
• Continuous Improvement: Implement and lead initiatives for improving testing processes, reducing errors, and increasing laboratory efficiency.
• Non-Conformance Management: Investigate and manage quality deviations, out-of-specification (OOS) results, and product recalls. Implement corrective and preventive actions (CAPA).

Team Leadership & Training

• Team Supervision: Lead and manage a team of analysts, technicians, and other QC staff.
• Training and Development: Provide technical training and mentorship to QC staff to ensure their knowledge of testing procedures, equipment usage, and safety protocols.

Equipment and Technology Management

• Calibration and Validation: Ensure all laboratory instruments and equipment are correctly calibrated, validated, and maintained by regulatory guidelines.
• New Technology Integration: Identify and integrate advanced testing technologies and methodologies to improve QC operations.

Product Quality and Release

• Batch Release: Collaborate with Quality Assurance (QA) to review and approve product batches for release to the market.
• Stability Studies: Oversee stability testing programs to ensure the shelf-life and efficacy of pharmaceutical products over time.

Health, Safety, and Environment (HSE)

• Safety Protocols: Ensure all QC activities comply with health, safety, and environmental regulations. This includes handling hazardous chemicals and waste disposal.
• Accident and Incident Reporting: Report and investigate laboratory accidents, ensuring preventive measures are implemented to avoid future occurrences.

Stakeholder Communication

• Cross-Departmental Collaboration: Work closely with production, quality assurance, R&D, and regulatory affairs departments to ensure that products meet quality standards.
• Customer Complaint Handling: Address and investigate product-related complaints, ensuring a swift and effective resolution.

Budgeting and Resource Management

• Resource Allocation: Manage the QC department's budget, ensuring the procurement of necessary materials, reagents, and equipment within financial constraints.
• Cost Control: Optimize QC operations to reduce wastage, improve resource utilization, and control costs without compromising quality.

Compliance with Local and International Standards

• Ensure compliance with local (Bangladesh) and international regulations (such as WHO, ICH guidelines, US FDA, and EU standards) related to pharmaceutical quality control.