Job Description

The
Senior QA Specialist for the Bulk Drug Substance (BDS) will be
responsible for management support, for providing oversight of quality
activities associated with the manufacturing and disposition of bulk drug
substances. He/she is responsible for ensuring that manufacturing, testing,
labeling, and storage of Bulk Drug Substances comply with all applicable
regulations. This responsibility includes the oversight of the company QMS
to ensure that quality and compliance requirements are followed in line with
business needs.

Principal
Responsibilities

·         Provide quality and cGMP
input and oversight for all start-up project activities through commercial
readiness for the BDS facility

·         Review and approval
technical support documentation. (Examples include cleaning, process, method validation).

·         Review and approval of
functional area documentation (SOPs, Work Instructions, technical reports and
protocols)

·         Participate in quality
risk assessments and provide quality oversight to ensure quality risk
assessments are effectively maintained/ controlled.

·         Provide support and
expertise for inspection readiness activities, during health authority
inspections including interaction with inspectors, responses to inspection
observations, to monitor progress of follow up actions.

·         Responsible for review
and approval of Master Batch Records in accordance with internal
procedures and GMP principles.

·         Responsible for review
and approval of Master electronic Batch Record recipes in accordance with internal procedures and GMP principles

·         Provide oversight of
quality management system activities including Preventive Maintenance,
Deviation Management and the Change Control Programs

·         Provide quality oversight
of calibration and preventative maintenance criticality assessments as required.

·         Author, review and
approve Quality Related Procedures as required

·         Support the Vendor
Management Program.

·         Support the Raw Material
Qualification Program.

·         Develop  and report quality metrics


Requirements

Qualifications

·         Minimum 5 years
in international pharmaceutical and/or biotech industry with increased level of
responsibility

·         Sound
awareness and understanding of pharmaceutical business, especially with regards
to quality and regulatory requirements

·         Demonstrated
success records in auditing and improvement processes

·         Ability to
operate efficiently in a complex matrix organization and international environment

·         Strong
mature leadership and interpersonal influencing skills

·         Strong
verbal and written communication skills with well-structured communication and
presentation ability to various audience levels

·         English
fluency written and spoken (the Company language)

·        Efficient
in SAP, EMDS, MES and Trackwise
.

Education

Academic degree in natural or applied
sciences (Pharmacy, biology, biotechnology, engineering)

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