Associate Specialist, Quality Assurance

Job Description

The Position

Ensure products release to the markets have met the standards and requirements of the Health Authority and comply with Organon policy.

Responsibilities:

• Perform end to end review and release of incoming material (i.e., raw materials, packaging components, PCM) and finished goods (manufactured, package products, and imported packaged products) in accordance with Health Authority and Organon requirement.
• Ensure the implementation and compliance of QMS in IPT.
• Collaborate with IPT during investigation of event such as customer complaint, deviation, and other investigation impacted IPT.
• Support supplier management related IPT, i.e., investigation of vendor related event.
• Support IPT in customer related target (i.e., delivery performance) and continuous improvement drive (i.e., IPT metric target and reduce cycle time).
• Generate Periodic Product Review report as per schedule.
• Support QRA as SME Quality.
• Support Site Lead Auditor for internal audit as auditor.
• Support Data Integrity implementation Maintain quality master data in SAP and interacts with CoE as required.
• Responsible to keep abreast site safety & quality requirement and specific compliance policy and standards at daily work.
• Demonstrate quality leadership behavior, promotes a quality culture, and proactively supports cGMP compliance.
• Promote the site SHE culture, including but not limited to, the interdependency safety culture.
• Perform Chapter QMS and/or SHE if assigned.

Required Education, Experience, and Skills:

Must have;

• Bachelor Degree of Pharmacy/Apothecary or relevant science degree.
• Have minimum 1 year experience in QA releaser field, or
• Fresh Graduate with excellence knowledge about pharmaceutical industry.
• Communicates information, asks questions and checks for understanding.
• Works only with established procedures, technologies, and methodologies.
• Proficient in English both oral and written.
• Applies technical and scientific knowledge.
• Sound understanding of CPOB and ASEAN regulatory requirements for pharmaceutical industries, GMP, GDP and Data Integrity.
• Good communication and teamwork skills.
• Detail oriented person.
• Good in time management and problem-solving skills.

Nice to have;

• Learning from routine work assignments to develop professional skillset, at entry level.
• Accountable for technical contribution to project team or sub-team.
• Applies regulatory knowledge and implementation.
• Begin/willingness to learn about proactive quality improvement ability.
• Begin/willingness to learn about customer and supplier management skill.
• Begin/willingness to learn about quality risk management knowledge and practices.
• Applies quality management system integration knowledge and practices.
• Begin/willingness to learn about quality audit management implementation.
• Begin/willingness to learn about deviation management ability.
• Begin/willingness to learn about inspection readiness and management ability.
• Begin/willingness to learn about quality management system knowledge.
• Applies ability for product control and disposition activities.