QA Assistant Manager - Pharmaceutical Manufacturing

Solutions+ (A Mubadala company); Dubai; On-site; AED 60,000 - 120,000; Full time

Job summary

A leading pharmaceutical manufacturer in Dubai is seeking a QA Specialist to oversee quality assurance operations, ensuring compliance with regulatory standards and leading quality initiatives. The ideal candidate will hold a degree in pharmacy and have 5-10 years of experience in Quality Assurance within pharmaceutical manufacturing. This role involves supervising QA staff, maintaining quality management systems, and engaging with cross-functional teams to uphold quality and safety standards.

Qualifications

• 5 to 10 years of experience in Quality Assurance in Pharmaceutical Manufacturing.
• Experienced in managing cross-functional quality aspects.

Responsibilities

• Supervise day-to-day operations of the QA department.
• Ensure compliance with UAE regulations and global standards.
• Drive process improvement initiatives to enhance quality.

Skills

Quality Management System

Compliance Verification

Operations control

Documentation Control

Material Control Skill

Problem-solving

Education

Bachelor's/master's degree in pharmacy

Tools

SAP

ERP

LIMS

MS Office Suite

Job description

Position Overview:

QA Specialist holds a senior position responsible review of cross functional quality aspects ensuring that all products meet the required quality, safety, and regulatory standards. This position is responsible for main QA function handling such as QMS, Validation, IPQA leading, etc. Responsibility includes preparation and review of GMP documents of cross-functional teams, including QC, production, warehouse, engineering, IT, HR and regulatory affairs, to align quality goals and ensure seamless operations.

Key Responsibilities:

• Supervise day-to-day operations of the QA department ensure efficiency and productivity. Provide guidance, mentoring, and support to the QA and cross functional team.
• Maintain constant audit readiness by ensuring all compliance documentation is current, complete, and accurate. Support during internal and external audits, ensuring that all required data and records are readily available for review.
• Ensure strict adherence to the company’s Quality Management System (QMS). Maintain proper documentation, training records, and follow all standard operating procedures (SOPs) for all activities.
• Good manufacturing Practice (GMP) shall be implemented in daily operations, including maintaining a safe and efficient work environment, appropriate follow of existing procedures, and the proper documentation. Ensure compliance with ALCOA+ principles for data integrity in all records. Review documentation including, SOPs, protocols, and logbooks.
• Allocate tasks to team members based on workload and individual capabilities. Monitor and assess work completion, performance, and compliance with quality standards.
• Supervise and mentor QA staff, ensuring 100% compliance with training programs. Conduct performance evaluations and ensure staff is competent in assigned work task. Foster a culture of teamwork, accountability, and continuous learning within the QA team.
• Drive process improvement initiatives to enhance quality and reduce documentation errors. Implement cost-saving measures while maintaining quality and compliance. Keep up-to-date with the latest guidelines and regulatory requirements to improve compliance.
• Collaborate with warehouse, production, quality assurance to address analytical concerns and provide technical support for troubleshooting.
• Ensure compliance with UAE Ministry of Health and Prevention (MOHAP) regulations, FDA, EMA, and WHO standards. Oversee and maintain the Quality Management System (QMS) for ensuring compliance with GMP, GLP, and other applicable regulatory frameworks.
• Support to QA Manager in the batch release process for raw/ Packing materials, in process/ intermediates and finished products. It includes review of batch records, serialization reports, logbooks, etc.
• Ensuring proper calibration, qualification, and maintenance of instruments and equipment's available in the organization. Review calibration schedules for all equipment's (e.g., HPLC, GC, UV-Vis spectrometers, etc.)
• Responsible for overall handling of validation activities at the site such as Process validation, cleaning validation, Packaging validation, Qualification (Instrument, Equipment, Systems – Water system, HVAC, Compressed air, etc.)
• Review of stability studies and ensuring compliance during the product lifecycle. Manage the stability program, ensuring samples are tested at appropriate intervals to support regulatory submissions.
• Handle the availability of necessary resources, stationary for the QA department. Identify and implement cost-saving measures while maintaining the highest standards of quality and compliance.
• Identifying and mitigating risks related to QA processes and product quality. Identify and review a Risk Management Program within the QA department to identify potential risks related to testing, equipment, and processes. Conduct risk assessments for critical QA activities and ensure mitigation plans are in place. Review and ensure compliance with risk-based approaches in Warehousing, production, product testing, stability studies, IT functions, and documentation.
• Evaluate and review suppliers, conduct audits, and ensure compliance with quality standards. Manage relationships to ensure consistent quality and minimal disruptions.
• Review method transfers for healthcare ensuring regulatory compliance and successful implementation.
• Ensuring accurate documentation and timely reporting of QA activities Review the creation, review, and approval of all departmental GMP documentation, including Batch records, SOPs, analytical records, batch release certificates, and stability data.

Required Skills & Qualifications:

1. Bachelor's/master's degree in pharmacy.
2. 5 to 10 years’ experience in Quality Assurance department in Pharmaceutical Manufacturing like Oral Solid Dosage Form, Semi Solid Dosage Form, Liquid Manufacturing and Injectables.
3. Experienced in SAP, ERP, LIMS, MS Office Suite.
4. Skilled in Quality Management System, Compliance Verification, Operations control, Documentation Control, and Material Control Skill.