About the job

As a Quality Assurance (QA) Specialist, you play a key role in partnering with site GMP operations and validation team in solving complex problems to ensure quality, safety, reliability, efficiencies and manage multiple quality systems including, but not limited to change controls, validation, deviations, laboratory investigations and CAPAs. He/she will assist in the daily operations for Batch Record Review, Batch Disposition/Release, complex deviations and continuous improvement projects. He/she will also ensure the compliance of qualification and validation with applicable regulatory requirements and company quality standards.

Accountabilities of the Quality Assurance (QA) Operations Specialist:

• Reviewing batch records and associated documentation. Overseeing review and approval of batch records and associated documentation.

• Overseeing batch release process to ensure compliance with regulatory requirements and company standards.
• Ensuring batch release activities comply with Good Manufacturing Practices (GMP).
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle
• Reviewing and approving investigation by leading highly complex root cause investigations for manufactured batches that have been implicated by deviations/laboratory investigation. Ensure that investigations are deep dive and scientifically justified to withstand scrutiny during batch review/disposition/release decision.
• Monitoring and analyzing batch release performance metrics.
• Monitoring the progress of effective corrective and preventive (CAPA) actions to ensure timely closure of CAPA (key site performance metrics). Collaborate with site operation on problem prevention activities and system improvements.
• Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness

• 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