Quality Control Head
Quality Control Head
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Quality Control Head will oversee and manage the QC activities of a diverse range of pharmaceutical dosage forms including capsulestablets injections and ointments ensuring adherence to MHRA standards GMP guidelines and company policies. This role is critical in ensuringthat all products meet the highest quality standards and are released incompliance with regulatory requirements.
Key Responsibilities
Quality Control Operations
- Manage all activities within the Quality Control (QC) department including raw material inprocess finished product and stability testing.
- Ensure all QC processes and testing adhere to MHRA guidelines GMP and other regulatory requirements.
- Ensure timely completion of testing activities to support production schedules and product release.
Regulatory Compliance
- Maintain compliance with GMP MHRA USFDA EUGMP and other applicable regulatory requirements.
- Prepare and participate in regulatory inspections audits inspections and customer visits.
- Ensure robust documentation of QC activities including test records specifications and certificates of analysis in compliance with GDP and data integrity standards.
- Ensure the successful of stability studies for all product types adhering to ICH guidelines.
- Implement corrective and preventive actions CAPAs) for qualityrelated issues identified during audits or inspections.
Team Management
- Lead train and mentor the QC team to enhance technical skills and regulatory knowledge.
- Develop and implement training programs for QC personnel to ensure adherence to MHRA and GMP standards.
- Assign tasks monitor performance and ensure efficient utilization of QC resources.
Laboratory Management
- Oversee the maintenance calibration and qualification of QC equipment and instruments.
- Review and approve validation protocols for analytical methods and instruments.
- Ensure the QC lab operates in a safe efficient and compliant manner.
- Manage laboratory investigations and outofspecification (OOS) results.
CrossFunctional Collaboration
- Coordinate with production quality assurance and R&D teams to resolve quality control issues.
- Provide technical expertise during product development scaleup and technology transfer activities.
- Support supply chain activities by ensuring the timely release of materials andproducts.
Requirements
Key Requirements
Educational Qualifications
- Bachelors or Masters degree in Pharmaceutical Sciences Chemistry or a related field.
Experience
- 15 years of experience in Quality Control within the pharmaceutical industry.
- Strong knowledge of MHRA regulations GMP and other international guidelines
- Proven expertise in QC activities for capsules tablets injections and ointments
- Prior experience in managing QC operations in an MHRAapproved facility is mandatory.
Skills and Competencies
- Strong leadership and team management skills.
- Expertise in analytical techniques including HPLC GC UV FTIR and other lab instruments.
- Proficiency in handling OOS investigations deviations and CAPAs.
- Excellent understanding of documentation practices GDP and data integrity principles.
- Ability to handle regulatory inspections and customer audits confidently.
- Stronganalytical problemsolving and decisionmaking skills.
Employment Type
Full-Time
