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Rekrutmen GSK Jakarta April 2021
Silakan simak info lengkapnya berikut
Site Name: IndonesiaDKI JakartaJakarta Timur Posted Date: Jan 22 2021
Are you looking for a quality compliance role where you can enhance your project management expertise in a state of the art manufacturing environment? If so, this Compliance Manager role could be an exciting opportunity to explore.
As a Compliance Manager, you will act as site expert on all matters relating to Quality Compliance; manage groups providing quality management system to the site and ensure that products released to market have gone through end to end quality assurance and compliance requirement based on cGMP, GSK Quality Management System and regulatory agencies standards.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Serve as site advisor on quality compliance issues
Responsible on implementation of CH Quality System, GSK QMS and regulatory requirement
Facilitate monthly Quality Council meetings for the site
Lead Inspection activities during regulatory inspections and audits
Host regulatory Inspections and write / coordinate the issue of a timely response to any observations including follow-up reports. Manage delivery of commitments to ensure timely follow-up and completion as committed
Host internal audits from CAG / A&A and write / coordinate the issue of a timely response to any observations including follow-up reports. Manage delivery of commitments to ensure timely follow-up and completion as committed
Manage an appropriate TTS management service for the site
Manage Change Control programs
Monitor and evaluate global regulatory policies and practices for impact on products supplied and managed
Manage Periodic Product Review process for the site
Manage Customer Complaint
Manage the Internal Audit and self-inspection process for the site
Manage Quality Alert, Quality Plan and Site Master File
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in Pharmacy
Minimum 5 years of working experience, preferably in pharmaceutical industry
If you have the following characteristics, it would be a plus:
Knowledge of cGMPs, local and international regulatory requirements (e.g., FDA, WHO, MHRA, EMA, etc.); especially in Good Laboratory Practice.
Good working knowledge of Quality System.
Strong analytical, numerical and reasoning skills.
Able to work in teams effectively.
Basic knowledge in manufacturing operations.
Good technical writing and verbal communication skills in English.
Good organization skills.
Ability to effectively summarize findings and draw conclusions, considering interfaces/ links between quality processes.
Proven track record of honesty and integrity.
Strong interpersonal and communication skills
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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