Senior Pharmaceutical Quality Assurance Analyst

Placements24; Queenstown; On-site; NZD 76,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plan

Paid time off

Professional development opportunities

Team collaboration in QA excellence

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Analyst to join our client’s team in Queenstown. The role focuses on ensuring products meet GMP, regulatory and quality standards, and involves maintaining and improving the QMS, handling CAPA, deviation management, and audits.

You will collaborate with production, R&D, and regulatory affairs, lead internal audits, review batch records, and provide training on QA principles to strengthen compliance and product integrity across the

Qualifications

• Minimum 5 years of experience in pharmaceutical quality assurance.
• Degree in Pharmacy, Chemistry, Biology, or related field; Master's preferred.
• GMP and ICH regulatory knowledge.
• Experience with QMS, change control, deviation management, and CAPA.
• Strong analytical, documentation, and communication skills.

Responsibilities

• Develop, implement, and maintain QA policies and procedures in line with GMP and regulatory standards.
• Conduct regular internal audits of manufacturing processes, documentation, and facilities.
• Review and approve batch records, validation protocols, and deviation reports.
• Investigate product quality complaints and CAPA to identify root causes.
• Monitor quality metrics and report findings to management.
• Collaborate with production, R&D, and regulatory affairs to resolve QA issues.
• Participate in external regulatory inspections and audits.
• Provide training on QA principles to personnel.
• Stay updated on industry trends and regulatory changes.

Skills

GMP knowledge

ICH guidelines

CAPA and deviation handling

Audit skills

QMS experience

Documentation and report writing

Analytical thinking

Regulatory communication

Education

Bachelor's degree in Pharmacy, Chemistry, or Biology

Master's degree is a plus

Tools

QMS software

Microsoft Office

Job description

About the Role

Our client, a leading innovator in the pharmaceutical industry, is seeking a highly skilled and motivated Senior Pharmaceutical Quality Assurance Analyst to join their dynamic team in Queenstown, Eastern Cape, ZA. This role is pivotal in ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. The ideal candidate will possess a strong understanding of regulatory requirements and a keen eye for detail. You will be instrumental in maintaining and improving our client's quality management systems, contributing directly to the integrity of life-saving medications. This is an exciting opportunity to advance your career within a reputable organization committed to excellence in pharmaceutical manufacturing and development. You will work in a collaborative environment, contributing to a culture of continuous improvement and stringent quality control.

Key Responsibilities

• Develop, implement, and maintain quality assurance policies and procedures in compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards.
• Conduct regular internal audits of manufacturing processes, documentation, and facilities to identify potential non-compliance issues.
• Review and approve batch records, validation protocols, and deviation reports to ensure adherence to established quality standards.
• Investigate product quality complaints and non-conformance events, identifying root causes and implementing corrective and preventive actions (CAPA).
• Monitor key quality metrics and performance indicators, reporting findings and recommendations to management.
• Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to resolve quality-related issues.
• Participate in external regulatory inspections and audits by health authorities and customers.
• Provide training to personnel on quality assurance principles and practices.
• Stay updated on industry trends, regulatory changes, and best practices in pharmaceutical quality assurance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A Master's degree is a plus.
• Minimum of 5 years of experience in pharmaceutical quality assurance or a related role within the pharmaceutical industry.
• In-depth knowledge of GMP, ICH guidelines, and other relevant pharmaceutical regulations.
• Proven experience with quality management systems (QMS), including change control, deviation management, and CAPA.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills, with the ability to clearly document findings and recommendations.
• Proficiency in Microsoft Office Suite and experience with quality management software.
• Ability to work effectively both independently and as part of a collaborative team in Queenstown, Eastern Cape, ZA.
• Demonstrated leadership potential and the ability to mentor junior team members.

Benefits

• Our client offers a competitive salary package commensurate with experience and qualifications.
• Employees enjoy comprehensive health insurance, retirement savings plans, and paid time off.
• There are also opportunities for professional development and continuous learning, including workshops and conferences.
• A supportive work environment and the chance to make a significant impact on public health are also key benefits.
• The company fosters a culture of innovation and encourages employees to contribute their ideas for process improvement.
• Join a team that values integrity, quality, and employee well-being in the beautiful region of the Eastern Cape.