PLANT Q&C MANAGER (OPERATIONS)-3721140905
Description
Quality & Compliance Responsibilities
- To ensure Quality & Compliance program are executed and conforming to established specifications and procedures.
- Ensure completeness of documentation prior to release of FG under NPD, cost / quality compliance project with complete Authorization for Product Release (APR) and meeting quality requirement.
- Responsible for batch record review and product release on timely manner.
- Management of INV & CAPA related to RM and FG and monitoring its implementation to ensure it is complete and close before Usage Decision (UD). CAPA management program including its verification and effectiveness monitoring.
- To address complaints appropriately and support in the complaint investigation process and implementation of Corrective and Preventive Action items.
- To provide support in the incoming Q&C and ensure samples tested and quality data review on timely manner for raw material samples.
Documentation Control Responsibilities
- Management of batch record, ensure reconciliation on monthly basis.
- To ensure that specifications are available, maintained and current.
- To ensure compliance to SOP requirements for specification and documentation.
Audit Support
- Be part of the assessment team for internal audit in JJM plant, external audit on suppliers and distributers/co-packers audit and provide support on audit action plan tracking and close-out.
Self Development
- To keep abreast of new technology, among other means, is by direct communication with other J&J Affiliates and Originating Company, have in-depth knowledge of products/raw material in order to provide technical support for new product introduction or profit improvement projects.
- Proactively pursue self learning to complete the competency requirement as per Competency model.
- Be a team member.
GMP and SHE (Safety Health and Environmental) compliance.
- Ensure team/division compliance to SHE and GMP.
- To ensure work station are clean and orderly.
Qualifications
-
Degree in Pure Science or equivalent discipline with minimum 8 – 10 years working experience in the related field
-
Strong GMP knowledge, good process excellence /situational analytical skill is an advantage
-
Good Quality Assurance, Quality System knowledge is mandatory (e.g. management review, complaint management, documentation & change control management, non-conformance, CAPA management, deviation management, promotional management, audit management)
-
Strong leadership and good talent development skill to lead a team to drive Q&C in S&M company
-
Excellent communication skills and good report writing skills
-
Good knowledge on ASEAN Cosmetic Directive guideline, local regulatory requirement, good warehousing & distribution practice, labeling requirement
Primary Location:Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization: Johnson & Johnson Sdn. Bhd. (8275)
Travel:No
Job Function: Quality (Generalist)
Description
Quality & Compliance Responsibilities
- To ensure Quality & Compliance program are executed and conforming to established specifications and procedures.
- Ensure completeness of documentation prior to release of FG under NPD, cost / quality compliance project with complete Authorization for Product Release (APR) and meeting quality requirement.
- Responsible for batch record review and product release on timely manner.
- Management of INV & CAPA related to RM and FG and monitoring its implementation to ensure it is complete and close before Usage Decision (UD). CAPA management program including its verification and effectiveness monitoring.
- To address complaints appropriately and support in the complaint investigation process and implementation of Corrective and Preventive Action items.
- To provide support in the incoming Q&C and ensure samples tested and quality data review on timely manner for raw material samples.
Documentation Control Responsibilities
- Management of batch record, ensure reconciliation on monthly basis.
- To ensure that specifications are available, maintained and current.
- To ensure compliance to SOP requirements for specification and documentation.
Audit Support
- Be part of the assessment team for internal audit in JJM plant, external audit on suppliers and distributers/co-packers audit and provide support on audit action plan tracking and close-out.
Self Development
- To keep abreast of new technology, among other means, is by direct communication with other J&J Affiliates and Originating Company, have in-depth knowledge of products/raw material in order to provide technical support for new product introduction or profit improvement projects.
- Proactively pursue self learning to complete the competency requirement as per Competency model.
- Be a team member.
GMP and SHE (Safety Health and Environmental) compliance.
- Ensure team/division compliance to SHE and GMP.
- To ensure work station are clean and orderly.
Qualifications
-
Degree in Pure Science or equivalent discipline with minimum 8 – 10 years working experience in the related field
-
Strong GMP knowledge, good process excellence /situational analytical skill is an advantage
-
Good Quality Assurance, Quality System knowledge is mandatory (e.g. management review, complaint management, documentation & change control management, non-conformance, CAPA management, deviation management, promotional management, audit management)
-
Strong leadership and good talent development skill to lead a team to drive Q&C in S&M company
-
Excellent communication skills and good report writing skills
-
Good knowledge on ASEAN Cosmetic Directive guideline, local regulatory requirement, good warehousing & distribution practice, labeling requirement
Primary Location:Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization: Johnson & Johnson Sdn. Bhd. (8275)
Travel:No
Job Function: Quality (Generalist)