Primary Activities include, but are not limited to:
This includes:-
Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
Interfacing with Corporate Global IT and other internal & external entities to align GxP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.
Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
Driving resolution of regulatory non-conformance for GxP computerized systems.
Assuring monitoring of system health, compliance and other metrics are communicated to key stakeholders.
Promoting GxP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
Representing Digital & Data Quality management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
Contributing to the development and/or maintenance of training programs in the principles of computerized systems validation, computer software assurance, and regulatory requirements in validation, data integrity, ALCOA principles, maintenance, and use of computerized systems.
Providing Quality Unit review/approval of SDLC documentation.
Mentor and provide guidance to junior members of the team.
WHAT YOU MUST HAVE
Qualification:
Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.
Requirements
Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
Min 5 years of experience in regulated pharmaceutical manufacturing industry.
At least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.
Strong understanding of the current pharmaceutical industry and applicable regulations(FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
Must dem
Benefits
Health insurance
Additional Information
Job Description
JOB PURPOSE
The essential functions include but are not limited to:
The Sr. Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
This includes involvement in all quality-related activities for computerized systems which are required by our company Quality Manual or with potential for impact on product quality, patient safety or data integrity.
The position will work closely with stakeholders and SME's from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
The Sr. Specialist DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.
Merck · - Singapore - Singapore (50 Tuas West Dr), Singapore