Senior Vaccine QA Specialist at Eva Pharma

6th of October, Giza, Egypt -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP, SOPs, Regulatory Requirements, Deviation Investigations, CAPA Implementation, Environmental Monitoring, Internal Audits, Risk Assessments, Data Integrity, Analytical Skills, Problem-Solving, Communication Skills, Coaching, Continuous Improvement

Industry

Pharmaceutical Manufacturing

Description

Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members. Job Summary We are seeking an experienced and highly skilled Senior Vaccine Quality Assurance Specialist to join our team. The ideal candidate will provide advanced QA oversight for vaccine manufacturing processes, ensure full compliance with GMP standards, and support continuous improvement initiatives to maintain excellence in product quality and patient safety. Responsibilities: Provide senior-level QA oversight for all vaccine manufacturing, filling, and packaging operations, ensuring strict adherence to GMP, SOPs, and regulatory requirements. Review and approve vaccine batch production records, investigations, protocols, and reports. Lead deviation investigations related to vaccine operations and ensure timely and effective CAPA implementation. Monitor and evaluate environmental conditions in classified areas, ensuring compliance and escalating any concerning trends. Coordinate and support internal audits, regulatory inspections, and external audits related to vaccine processes. Participate in change control assessments and risk assessments for vaccine equipment, materials, and processes. Provide guidance, training, and support to junior QA specialists and production teams on GMP, data integrity, and documentation standards. Identify quality gaps and drive continuous improvement initiatives to enhance vaccine process robustness and compliance. Ensure proper documentation practices (GDP) and data integrity (ALCOA+) throughout all vaccine-related activities. Bachelor’s degree in Pharmacy (mandatory). 3–4 years of experience in pharmaceutical Quality Assurance; vaccine manufacturing experience is strongly preferred. Strong knowledge of cGMP, GDP, CAPA systems, change control, and deviation management. Experience supporting audits and inspections (FDA, EMA, WHO, or local authorities is a plus). Solid understanding of cleanroom controls, aseptic practices, and environmental monitoring requirements. Strong analytical, problem-solving, and decision-making skills. Excellent communication skills and ability to collaborate cross-functionally. Proven ability to coach and guide junior team members.

Responsibilities

The Senior Vaccine QA Specialist will provide senior-level QA oversight for vaccine manufacturing processes, ensuring compliance with GMP and regulatory standards. They will also lead investigations and drive continuous improvement initiatives to enhance product quality and patient safety.