Oq Batch Release
5 months ago
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Voltaren, and many more - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
We are currently looking for OQ Batch Release that will be responsible for ensuring our release products manufactured and packed at Pulogadung Site based on their marketing and manufacturing authorisations and ensure all relevant activities comply with all GMP and Regulatory requirements. This role will be also given additional responsibilities to support incident and deviation investigations, become the owner of management monitoring, participate with internal auditing, Gemba activities, investigation rapid response, coaching, CAPA/Effectiveness check approval assistance, and batch record review asssistance as required.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Become the responsible Pharmacist for the released of finished products.
- Collate all required documents and data records for each batch of product assessed for disposition.
- Perform batch reviews in a consistent/standardised manner in accordance with the requirements of its Manufacturing Authorisation Holder (MAH) as per the Technical Terms of Supply (TTS) and the Quality Agreements with the Local Operating Companies (LOCs).
- Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
- Promote and exercise Gemba and walk through of areas and processes to drive improvement and as an advocate for change.
- Assist in root cause analysis, problem solving, mentoring, corrective and preventive action development, and coaching of Excellence in Deviation Management (eDM) principles of investigation.
- Ability to think strategically and use sound judgment.
- A champion of change to improve systems and processes.
- Perform duties in a compliant manner and behave in accordance with site LSOP, Haleon EHS standards and guidelines, and relevant legal requirements.
- Why you?_
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Education background as Pharmacist
- 3 years’ experience in a pharmaceutical company in the relevant Operational Quality/Quality Control Departments.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Understanding of appropriate directives, standards, policies and guidelines, and ability to implement appropriately, i.e. QMS, cGMP, relevant regulatory requirements for all markets, etc.
- Knowledgeable of the materials, products, processes, and quality systems.
- Able to demonstrate appropriate qualification, expertise, and on-going personal development to meet Local Authority expectations.
- Ability to communicate with a wide variety of people at all levels, both withing site and externally through appropriate skills.
- Excellent written communication skills.
- Excellent team and personal organisational/planning skills.
- Demonstrate willingness to collaborate and share/exchange knowledge as appropriate.
- Strong analytical, numerical and reasoning skills.
- Ability to effectively summarize findings and draw conclusions, considering interfaces/links between quality processes.
- Must have proven track record of honesty and integrity.
- Confident, strong and high integrity
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by
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