Quality Assurance Specialist

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.

Preferrable Education, Experience, and Skills:

• 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.
• Learning from routine work assignments to develop professional skillset, at entry level.
• Communicates information, asks questions and checks for understanding.
• Accountable for technical contribution to project team or sub-team.
• Works only with established procedures, technologies, and methodologies.
• Proficient in English both oral and written.
• Applies regulatory knowledge and implementation.
• Applies technical and scientific knowledge.
• 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.
• 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.

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R526183