IPQA DEPUTY LEAD

  • Agensi Pekerjaan CityRecruit Sdn Bhd
  • Iskandar Puteri, Johor
  • 09 Jan, 2019
Full time Engineering

Job Description

JD for IPQA Deputy Lead

Sl. No.

Job Responsibilities

1

Responsible for In process – QA and lead a team of IPQA professionals for ensuring total compliance of quality assurance functions of Drug Product Manufacturing Block as follows.

2

Responsible for issuance, control, review, reconciliation and retrieval of GMP documents like Batch Manufacturing, Packing, Dispatch Records, Formats, and Logs.

3

Responsible for monitoring quality assurance of manufacturing operations to ensure that those are carried out as per laid down instructions in batch documents, Standard Operating Procedures and related GMP documents. Responsible to ensure that highest quality and cGMP standards, data integrity requirements are followed. Should have prior experience in working with sterile aseptic formulation.

4

Strategic planning and scheduling of activities within team members of In process Quality Assurance and coordination with cross functional teams to ensure smooth, cGMP and quality compliant manufacturing process at shop floor.

5

Responsible for batch document and associated documents review, batch release

6

Allocating job responsibilities to the IPQA team members, ensuring effective training, mentoring, work delegation, monitoring team members to execute effective QA function.

7

Responsible to lead internal and external audits.

8

Responsible to nurture a well-trained and motivated team as well as establish and maintain a positive community relationship with the peers, superiors and subordinates.

9

Responsible for allocating key performance areas / quality goals for the team members for continuous quality improvement and training the IPQA team.

10

Involve in continuous improvement plans by effective quality gap analysis programs, from the learnings obtained as part of internal and external audits as well as with changes in the regulatory expectations.

11

Responsible for ensuring GMP rounds and reporting observations as per procedure. Inculcating quality culture within team and area of work in cross functional team.Responsible for ensuring timely reporting deviations, approve immediate action plan, assess impact, complete investigations and approve, monitor CAPA.

12

To approve the documents and records prepared for the applicable section as and when required.

13

Change Management and Deviation Management Panels which involves assessing the changes and deviations with the panel members, responsible for assessing the impact of the change and deviation as well as draw out an effective action plan for change managements and corrective action preventive action plans to prevent the recurrence of deviations.

14

Responsible for trending and compilation and approval of Annual Product Reviews as per defined procedures and ensure that media fill is carried out as per the schedule.

15

Ensure that manufacturing operations are executed using approved materials and procedures, trained / qualified / certified people, validated processes, calibrated instruments, qualified and validated equipment’s, facility.

Job Requirements

Qualification
Bachelor Degree
Professional Degree


Field of Study
Engineering (Chemical)
Chemistry

Additional Information

Kindly contact Mr Hanafi at 019-7851503 / 07-230 5453 ext 21 email [ mohd.haron@cityrecruit.com.my ] for further details 

Skill Level

Senior Executive

Salary Range

RM4000 - RM8000