RC&QMS Section Manager
- University graduate or higher in appropriate field.
- Appropriate level of experience( Minimum 5 years experience in pharmaceutical manufacturing )
- Broad base of knowledge (Be familiar with GMP, GLP and other relative national regulation; GQP/GQG/FPG/CAP requirements.)
- Commercial awareness of business environment
- Ability to obtain information objectively
- Communication and influencing abilities
- Ability to add value to the business
- Understanding of 'Systems' and 'Process' approaches
- Can insist on "Do the right thing".
- Can be fairness and openness in decision making
- Hands on with computers for routine work.
- Good English oral and writing skills.
- Good training skill
Job Purpose 岗位目的:
Manage and mitigate significant quality & regulatory risks in GSKT through risk identification and full use of available risk management process.
Ensure site regulatory compliance to GSK & regulatory standards.
Ensure that all GSKT site processes and systems meet high GMP and quality standards to comply with international, corporate and local requirement.
Ensure effective site QMS implementation process based on risk approach.
Ensure current QMS used in site.
1.Approve all the specifications and test methods for raw materials, packaging materials, bulk and finished products to ensure compliance to registered details.
2.Ensure registration documents for exported products are submitted to the relevant markets correctly.
3.Ensure notify authorities of regulatory related issues.
4.Establish systems to comply GMP, International, Corporate and Local standards by continuous improvement.
5.Perform GMP/QMS/SOP training to address major compliance gaps and introduce best practices.
6.Establish and implement internal auditing system, review and follow up any deviations in internal and external quality assessment.
7.Work with market regulatory team to support new product introduction regulation compliance.
8.Support NPI team to prepare new product introduction required submission dossier.
9.Organize and monitor product recall,
10.Organize GMP meeting to communicate responsibilities and expectations with other department. Deliver promised results in each GMP meeting.
11.Assist Head of Quality to organize Quality council.
12.Work as site Audit Process Manager to ensure site internal audit system effectiveness.
13.Establish effective QMS implementation process for maintain continues quality performance in site.
14.Establish effective QMS gap analyse system.
15.Establish effective system to ensure site SOP align with current QMS.
16.Seek improvement opportunity for QMS effective implementation at GSKT
17.Deliver training on QMS implementation process.
18.Ensure right person to take QMS gap analyse and maintain QMS owner list.
19.Other jobs assigned by Head of Quality.
20.Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures
You may apply for this position online by selecting the Apply now button.
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