Senior Qa Engineer

Role & responsibilities

Position Overview:

We are seeking a highly skilled and experienced Senior Engineer in Quality Assurance to join our dynamic team at BiOZEEN. The successful candidate will play a key role in ensuring the highest standards of quality, compliance, and efficiency in our biopharmaceutical equipment qualification used for vaccine manufacturing processes.

1) We are looking for an efficient, skilled, creative and experienced Senior Engineer - Quality Assurance to join BiOZEEN.

2) The successful candidate will work closely with the Dy. Manager Quality Assurance to ensure that our products meet quality and regulatory requirements. This includes overseeing and review of the Qualification of equipment as per testing protocol and procedures.

3) The successful candidate must have the temperament and reporting skills for conducting audits and investigations to ensure compliance to standards and guidelines.

Key Responsibilities:

1)

Participate in internal and external audits, addressing findings and implementing corrective actions.

2) Quality Testing & Equipment Qualification:

Competent to perform/write: Design Qualification

Installation Qualification (IQ) & Operational Qualification (OQ) of Equipment

Risk Analysis and HAZOP

Others as per Project Requirement.

Review of Manufacturing Documents, Component Literature/specifications and Testing documents, including batch records, SOPs etc.

Execution of Pre-FAT, FAT & SAT.

3)

Identify opportunities for optimization in testing/qualification and cost reduction while maintaining high-quality standards.

Collaborate with cross-functional teams to implement continual improvements at BiO ZEEN.

4)

5)

6)

Stay updated on industry trends and share knowledge within the team.

Qualifications and Requirements:

1) Bachelors or master’s degree in a relevant field such as Biotechnology, Biology, Chemistry, or Mechanical Engineering.

2) At least 4 years of experience in Quality Assurance in a biotechnology manufacturing environment.

3) Experience with regulatory compliance, including FDA regulations, ISO standards, and cGMP guidelines.

4) Strong knowledge of Quality Systems and procedures, including auditing, investigations, and CAPA/CARA.

5) Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.

6) Proficient with creating and submitting status reports and QA Dept. objective matrices.

7) Strong analytical and problem-solving skills, with the ability to manage multiple projects simultaneously.

8) Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.

Preferred candidate profile