Senior Quality Assurance Manager

Description :

PharmaSecure is a global track-and-trace, product authentication, and consumer engagement company that has helped protect over 8 billion packages through its technology-enabled solutions on hundreds of manufacturing lines. The codes printed are generated using its patented, encryption-based algorithm that provides unmatched security.

It has a proven track record of implementing minimal changes to the existing manufacturing process and negligible downtime of manufacturing lines by providing a solution that seamlessly integrates into the existing operations.

Its proven serialization capabilities have enabled large pharmaceutical companies to meet different traceability requirements, as it ensures that pharma manufacturers exporting to various countries maintain regulatory compliances.

Other than being experts in global track-and-trace, product authentication, and consumer engagement, PharmaSecure is also an OEM for efficient machines to provide a full suite of software and hardware solutions under one umbrella.

Overview of Role :

The Senior Manager Quality will be responsible for ensuring the quality and compliance of software applications, IT systems, and related processes in alignment with regulatory requirements in the pharmaceutical sector.

The role involves testing, validating, and verifying that all systems meet industry standards, including GxP compliance, 21 CFR Part 11, and other applicable regulations.

The candidate should have a keen eye for detail, a strong understanding of pharma industry guidelines, and experience in software testing and validation.

Principal Responsibilities and Accountabilities :

Software Testing & Validation :

- Design and/or review manual and automated test cases for IT systems.

- Perform validation of pharma-related IT systems as per GMP guidelines.

- Ensure compliance with 21 CFR Part 11 and other global pharmaceutical regulatory standards.

- Ensure testing for all IT systems and applications is in-line with PhrmaSecure QMS.

- Supervise Manage defect tracking and resolution with development teams.

Documentation :

- Prepare/Review validation documentation, including Test Plans, Test Scripts, Validation Protocols, and Reports (IQ/OQ/PQ).

- Maintain records of test results, issues identified, and corrective actions.

- Assist in maintaining Standard Operating Procedures (SOPs) and ensuring they are followed during testing and validation activities.

Regulatory Compliance :

- Ensure IT systems and processes adhere to industry-specific regulatory standards (GxP, GMP, GAMP 5, and Data Integrity requirements) and maintain continuous compliance.

- Oversee both QA and Regulatory Affairs responsibilities to ensure alignment with evolving pharmaceutical and IT regulations.

- Act as the primary liaison for internal and external audits, ensuring all IT systems meet regulatory and compliance standards.

- Stay updated on regulatory changes affecting pharma IT systems and incorporate new requirements into QA and regulatory processes.

Risk Management :

- Conduct risk assessments and develop mitigation strategies for IT systems.

- Identify potential risks and issues early in the development lifecycle to prevent system failures post-deployment.

Collaboration & Support :

- Work closely with cross-functional teams (IT, Development, Manufacturing, Regulatory, etc.) to ensure a smooth transition of systems from development to production.

- Provide training and support to end-users for validated IT systems.

- Assist with internal and external audits, ensuring IT QA compliance is maintained.

Competencies :

- Fluency in English.

- Excellent written and verbal communication skills.

- Excellent teamwork skills.

- Excellent attention to detail, quality and control.

- Proven ability to influence cross-functional teams without formal authority.

Required experience and knowledge :

plus years of experience in IT Quality Assurance, preferably in the pharmaceutical or life sciences sector.

- Proven track record of validating GxP-compliant systems in a regulated environment.

- Familiarity with GAMP 5, 21 CFR Part 11, Data Integrity, and other relevant pharma regulations.

- Bachelor's or Master's degree in Information Technology, Computer Science, or a related field.

- Certifications like ISTQB, Six Sigma, or relevant QA certifications are a plus.

- Hands-on experience with test management tools (JIRA, HP ALM, etc.).

- Knowledge of SQL and scripting for database and application testing.

- Familiarity with automated testing tools (Selenium, QTP, etc.).

- Experience with ISO standards 9001 and 27001.

- Knowledge of Pharma machines validation will be an added advantage.