Job Detail

JOB RESPONSIBILITIES

1 To follow the established procedures and policies of the company pertaining to EHS and ensure  implementation of safety practices at work place
2 To involve in preparation HAZOP, aspect/impact register and reviewing the adequacy where ever applicable
3 Coordination with RND/Production and development team for tech transfer
4 To lead the debottlenecking activity by identifying the potential rate limiting steps and suggest/develop innovative solutions. To evaluate and improve on processes in manufacturing systems
5 Responsible for facility fit assessment for new product in coordination with RND and Manufacturing teams. Propose operational strategies towards ensuring the optimal utilization of the facility
6 To initiate and execute the COGs reduction Projects through operational improvements
7 Coordination with cross functional team for investigation and closure of Deviations/OOS/OOT and CAPA
8 To ensure and monitor the compliance with the requirements of cGMP and global  regulatory standards
9 Responsible for data collection, interpretation and preparation of Operational reviews and Quality matrix
10 To participate in management reviews of process performance, product quality and
of the quality management system
11 To Coordinate for CAPEX and Annual Budget in coordination with finance and operation team
12  Ensuring the availability of all the requirements to execute the project activities
13 Accomplishes department objectives by managing the team members.  Establishes strategic goals by Planning and evaluating the activities with team

1 To follow the established procedures and policies of the company pertaining to EHS and ensure  implementation of safety practices at work place

2 To involve in preparation HAZOP, aspect/impact register and reviewing the adequacy where ever applicable

3 Coordination with RND/Production and development team for tech transfer

4 To lead the debottlenecking activity by identifying the potential rate limiting steps and suggest/develop innovative solutions. To evaluate and improve on processes in manufacturing systems

5 Responsible for facility fit assessment for new product in coordination with RND and Manufacturing teams. Propose operational strategies towards ensuring the optimal utilization of the facility

6 To initiate and execute the COGs reduction Projects through operational improvements

7 Coordination with cross functional team for investigation and closure of Deviations/OOS/OOT and CAPA

8 To ensure and monitor the compliance with the requirements of cGMP and global  regulatory standards

9 Responsible for data collection, interpretation and preparation of Operational reviews and Quality matrix

10 To participate in management reviews of process performance, product quality and

of the quality management system

11 To Coordinate for CAPEX and Annual Budget in coordination with finance and operation team

12  Ensuring the availability of all the requirements to execute the project activities

13 Accomplishes department objectives by managing the team members.  Establishes strategic goals by Planning and evaluating the activities with team

1 To monitor the compliance with the requirements of Good Manufacturing Practice
2 To review the instructions relating to production operations and to ensure their implementation
3 To ensure the availability of all BMR’S,CKL ,LS ,ECC and other documents for batch initiation
4 Coordination for preparation of MFR,BMR’S, SOP, EOP, Checklists, Log Sheets and related documents
5 To ensure that all production deviations, OOS and OOT are reported and evaluated and that critical deviations are investigated and the conclusions are recorded. All these are closed within the initial timelines
6 Ensure implementation of CAPA and they are closed within the initial timelines
7 Responsible for coordination for internal /external  audits and closure of the observations on time with appropriate CAPA
8 To ensure Change Management are initiated and closed as per defined timelines
9 To ensure that the initial and continuous training of Production personnel is carried out and adapted according to need.
10 To ensure the availability of updated training records for employees and the records are real-time updated without any lapses
11 Coordination for impact assessment , customer compliant and ensuring closing these on time
12 Coordination for requalification of equipment and equipment qualification planner
13 Responsible for shift marking of all employee
14 Ensure the archival room is presentable and all the documents are tracked and available
15 Preparation and approval of DS organogram. Updating the OC based on the changes and requirement
16 Ensure the QBMS and GMP of the area is reviewed periodically

Kindly contact Mr Hanafi at +60 19-785 1503 for further details or send your resume to [mohd.haron@cityrecruit.com.my]