Quality Assurance QA Specialist

• Representing the site in the CoP led by global and, if requested, participating in the CoE for batch release and ensuring local communication.

• Reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre-defined timeline. Ensuring proper documentation of deviations, non-conformances, and corrective actions. Ensuring proper evaluation (validation expertise) of change controls

• Ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards

• Conducting regular audits of production processes to identify and address potential quality issues.

• Participating in internal and external audits and regulatory inspections providing support and documentation.

• Developing and implementing risk management strategies to mitigate potential quality issues.

• Fostering a culture of quality and continuous improvement across the organization

Other responsibilities:

• Coordinates on the Annual Product Review (APR).

• Participate actively in the GEMBA walk-down during investigation to triage and resolve on-the-floor manufacturing issues.

• Training: To complete all GMP mandatory and related training.

• Facilitate daily level 2 quality meeting. Backup as QA Executive for QA team. Support monthly joint GEMBA- backup as QA Specialists for QA team.

• Play a proactive role by complying and adhering to HSE guidelines. Embrace Zero Incident Mindset and adopt the responsibility of HSE protection policies and Life Saving Rules (LSR).

Key involvement in decision-making process:

• Approve documentation for batch disposition and update corresponding digital tool to allow release (D)
• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)
• Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)
• Resolve issues and deviations and take disposition decision on lots (D)
• Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
• Request quality improvement initiatives and strategies (D)
• Identify discrepancies and corrective/preventive actions that need to be taken (D)
• Review documentation for batch disposition (A)
• Review and approve the qualification and validation quality documents (A)
• Advise on how to present a topic and answer specific questions (A)
• Advise on initiatives to promote a quality-focused culture (A)
• Escalate to upper management any failure in GMP execution on shopfloor (I)
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)

Experience:

• You hold an engineering/Science Degree or equivalent from recognised institution with 3-5 years of quality operations experience within the pharmaceutical industry or equivalent holders with a combination of education and relevant work experience. Experience in batch release, deviation and investigation handling is preferred
• A quick learner with a proactive ‘Can-do’ attitude. Adaptable and flexible in managing rapidly changing priorities, with a commitment in supporting site activities with alignment to the manufacturing schedule. Discipline and assertiveness in the decision-making and execution of quality related issues.
• Exceptional time management skills with strong attention to detail.
• High adaptability and ability to work independently and write/review reports. Strong interpersonal relationships in establishing good partnerships with cross functional teams.
• Good verbal and written communication skills; effective communication and presentation skills and a team player

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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