104 Quality Assurance Specialist jobs in Bahrain
Pharmaceutical Quality Assurance Specialist
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Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations.
- Conduct internal audits and inspections to assess compliance with established quality standards and identify areas for improvement.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Participate in external audits by regulatory agencies and customers.
- Manage change control processes, ensuring all changes are properly evaluated, documented, and implemented.
- Develop and deliver quality training programs to personnel across the organization.
- Monitor key quality metrics and provide regular reports to management.
- Stay up-to-date with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
- Contribute to the continuous improvement of quality processes and systems.
- Support the qualification and validation of equipment, processes, and analytical methods.
- Review and approve raw material and finished product testing results.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science field.
- Minimum of 4 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Strong understanding of GMP, ISO, and other relevant regulatory guidelines.
- Experience with QMS implementation and maintenance.
- Proficiency in conducting audits, investigations, and managing CAPA systems.
- Excellent attention to detail, analytical skills, and problem-solving abilities.
- Strong written and verbal communication skills, with the ability to document findings clearly and concisely.
- Ability to work independently and collaboratively in a team environment.
- Familiarity with pharmaceutical manufacturing processes is a plus.
- Proficiency in Microsoft Office Suite and quality management software.
- Relevant professional certifications are an advantage.
Pharmaceutical Quality Assurance Specialist
Posted today
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Pharmaceutical Quality Assurance Specialist
Posted today
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with regulatory requirements (e.g., GMP, ISO).
- Conduct internal audits and inspections to assess compliance with established quality standards and identify areas for improvement.
- Review and approve batch records, validation reports, and other quality-related documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, determining root causes and implementing corrective and preventive actions (CAPAs).
- Participate in external audits and regulatory inspections, serving as a subject matter expert.
- Develop and deliver quality training programs for relevant personnel.
- Monitor quality metrics and key performance indicators (KPIs), reporting on trends and recommending improvements.
- Ensure that all manufacturing processes and products meet predefined quality standards and regulatory requirements.
- Manage change control processes, evaluating the impact of proposed changes on product quality.
- Stay up-to-date with current pharmaceutical quality regulations and industry best practices.
- Collaborate with various departments, including R&D, manufacturing, and regulatory affairs, to ensure a cohesive approach to quality.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related Life Science field.
- Minimum of 4 years of experience in a Quality Assurance role within the pharmaceutical industry.
- Strong understanding of Good Manufacturing Practices (GMP) and other relevant quality regulations.
- Experience with internal and external audits, regulatory inspections, and QMS implementation.
- Proficiency in deviation investigation, root cause analysis, and CAPA development.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong attention to detail and commitment to accuracy.
- Effective communication and interpersonal skills, with the ability to collaborate cross-functionally.
- Experience with validation processes (e.g., process validation, cleaning validation) is a plus.
- Familiarity with documentation control systems and batch record review.
Remote Quality Assurance Specialist
Posted 1 day ago
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Key Responsibilities:
- Develop, implement, and refine quality assurance protocols and checklists for cleaning operations.
- Conduct remote assessments of cleaning service delivery through data analysis, client feedback, and operational reports.
- Identify non-conformance issues and develop corrective action plans to address quality gaps.
- Collaborate with operations managers and cleaning teams to ensure consistent application of quality standards.
- Monitor industry best practices and regulatory requirements related to cleaning and sanitation.
- Analyze trends in quality data to drive continuous improvement initiatives.
- Prepare detailed reports on quality performance and present findings to senior management.
- Train and mentor cleaning staff on quality standards and procedures.
- Stay abreast of new cleaning technologies and methodologies that can enhance service quality.
- Maintain accurate records of quality control activities and audit findings.
The ideal candidate will have a Bachelor's degree in a related field or equivalent professional experience. A minimum of 4-6 years of experience in quality assurance, preferably within the cleaning, hospitality, or facility management industries, is required. A strong understanding of cleaning methodologies, safety standards, and hygiene practices is essential. Excellent analytical and problem-solving skills, coupled with a keen attention to detail, are a must. Proficient in data analysis and reporting tools is necessary. Exceptional written and verbal communication skills are crucial for effective collaboration and reporting in a remote setting. The ability to work independently and manage time effectively is paramount.
Pharmaceutical Quality Assurance Specialist
Posted 1 day ago
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Lead Pharmaceutical Quality Assurance Specialist
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Principal Pharmaceutical Quality Assurance Specialist
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Senior Pharmaceutical Quality Assurance Specialist
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Responsibilities:
- Develop, implement, and maintain quality management systems in compliance with regulatory requirements.
- Conduct internal audits and participate in external audits by regulatory agencies and partners.
- Review and approve quality-related documentation, including SOPs, batch records, and validation documents.
- Investigate deviations, OOS results, and customer complaints, implementing CAPAs.
- Provide training to personnel on GMP, quality procedures, and compliance requirements.
- Serve as a subject matter expert on quality assurance principles and pharmaceutical regulations.
- Assess and qualify suppliers and vendors for raw materials and services.
- Monitor quality metrics and trends, identifying areas for continuous improvement.
- Contribute to regulatory submissions and inspections.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 5 years of experience in pharmaceutical Quality Assurance.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory standards.
- Experience with audits, investigations, CAPA management, and change control.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent written and verbal communication skills.
- Ability to work effectively both independently and as part of a cross-functional team.
- Experience with quality control testing is a plus.
Senior Pharmaceutical Quality Assurance Specialist
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Key Responsibilities:
- Quality Systems Management: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements.
- cGMP Compliance: Ensure all manufacturing and laboratory operations adhere to cGMP guidelines and other relevant pharmaceutical regulations.
- Audits: Conduct internal and external audits of manufacturing facilities, suppliers, and processes to assess compliance and identify areas for improvement.
- Deviation & CAPA Management: Investigate deviations from standard procedures, implement corrective and preventive actions (CAPA), and track their effectiveness.
- Document Control: Manage the lifecycle of quality-related documents, including SOPs, batch records, and validation protocols.
- Quality Reviews: Review and approve batch records, analytical data, and validation reports.
- Change Control: Participate in the change control process, assessing the impact of changes on product quality.
- Training: Provide training to personnel on quality assurance procedures and cGMP principles.
- Regulatory Support: Assist with regulatory inspections and submissions.
- Continuous Improvement: Drive continuous improvement initiatives within the quality assurance department.
Qualifications:
- Education: Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree is preferred.
- Experience: Minimum of 5-7 years of experience in pharmaceutical quality assurance or quality control, with a deep understanding of cGMP.
- Regulatory Knowledge: Comprehensive knowledge of pharmaceutical regulatory requirements (e.g., FDA, EMA) and quality standards.
- Auditing Skills: Proven experience in conducting internal and external audits.
- Analytical Skills: Strong analytical and problem-solving skills.
- Documentation Skills: Excellent technical writing and documentation skills.
- Communication: Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.
- Attention to Detail: Meticulous attention to detail and a commitment to accuracy.
This is an on-site role located in Muharraq, Muharraq, BH . Be part of a team committed to delivering safe and effective pharmaceutical products.
Lead Pharmaceutical Quality Assurance Specialist
Posted today
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Key Responsibilities:
- Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with global regulatory standards.
- Oversee and conduct internal audits of manufacturing processes, quality control laboratories, and documentation to identify areas for improvement and ensure adherence to GMP.
- Manage external audits by regulatory agencies and third-party inspectors, ensuring a smooth and successful process.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Develop and implement training programs for staff on quality assurance procedures, GMP, and regulatory requirements.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Monitor key quality metrics and prepare reports for senior management on the status of the QMS and product quality.
- Stay current with evolving regulatory landscapes and industry best practices.
- Participate in process validation and equipment qualification activities.
- Manage and mentor a team of Quality Assurance professionals.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a leadership or supervisory role.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Proven experience in conducting and managing audits (internal and external).
- Strong understanding of pharmaceutical manufacturing processes, quality control testing, and documentation.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills.
- Experience with CAPA systems and deviation management.
- Proficiency in using quality management software and standard office applications.
- Ability to work effectively in a cross-functional team environment.
- Experience with sterile manufacturing or other specialized pharmaceutical production is a plus.
This is a vital role for ensuring the integrity and quality of our pharmaceutical products, offering significant career growth opportunities within a reputable organization.