Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree, Biology, Science & Technology, BioTechnology or equivalent.
At least 8 year(s) of working experience in the related field is required for this position.
Applicants must be willing to work in Nusajaya.
Preferably Managers specializing in Quality Assurance or equivalent from Pharma/Food Industry
3 Full-Time position(s) available.
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.
Responsible for issuance, control, review, reconciliation and retrieval of GMP documents like Batch Manufacturing, Packing, Dispatch Records, Formats, and Logs.
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.
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.
Allocating job responsibilities to the IPQA team members, ensuring effective training, mentoring, work delegation, monitoring team members to execute effective QA function.
Responsible to lead internal and external audits.
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.
Overall responsible for review and approval of protocols, ensuring process validations, cleaning validations, hold time studies, transport validations and product related validations are planned, executed as per laid down procedures and schedules, review and approval of reports, implementation of recommendations.
Strategic planning and scheduling of activities within team members of Quality Assurance and coordination with cross functional teams to ensure smooth, cGMP and quality compliant manufacturing process.
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.
Ensure that CPP and CQAs are trended and if any out of trend is investigated as per the approved procedures.
Ensure that Validation activities are carried out using approved materials and procedures, trained / qualified / certified people, calibrated instruments, facility etc.