Senior Specialist QA QC & Release

FUNCTION SUMMARY

The role is responsible for the Quality oversight of Raw Materials and Drug Substance batches release, oversight on all related quality event (e.g. deviations, investigations, CAPA, change control), confirming compliance with GMP, specifications.

The role maintains a strong collaboration with other functions (manufacturing, QC, Supply Chain) and Technical SME and promotes continuous improvement and Quality culture.

The tenant of the function ensures product expertise to support investigations and change management.

DUTIES AND RESPONSABILITIES

• Collect, review and complete all records required for Raw Materials batch review and disposition.
• Collect, review and complete all records required for Drug Substance batch review, disposition and shipping.
• Assure QA representative responsibilities in the management of major changes to starting and raw materials, Drug Substance, QC testing, manufacturing process and packaging components.
• Approve LIMS master data changes
• Write, update, and approve quality documentation (SOP, WI, specifications).
• Ensure QA oversight for all quality events related to the area of responsibility.
• Actively contribute and provide product expertise for major deviations impact assessments and investigation.
• Promote Quality and compliance initiatives. 
• Contribute to the maintenance of Incyte’s Quality System.
• Support Health Authorities’ inspection readiness programs and act as Subject Matter Expert in area of expertise.
• Interpret and implement GMP, regulatory requirements, and Quality Systems regulations applicable to QC.
• Support QA team in related support functions including incoming goods and vendor assessments.
• Foster understanding and application of cGMPs by Bioplant employees.
• Perform all responsibilities in accordance with company policies, procedures, applicable regulations, and safety requirements.
• Promote a strong culture of Quality, business integrity, and ethics.
• Act within compliance and legal requirements as well as company guidelines.

REQUIREMENTS

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
• Thorough knowledge of cGMP, cGDP and global regulatory requirements applicable to pharmaceutical manufacturing and testing.
• Demonstrate strong Interpersonal skills and ability to effectively interact with multiple disciplines.
• Strong verbal and written communication skills with structured communication and presentation ability.
• Compliance focused whilst assuring a pragmatic and risk-based approach to quality.
• Fluent in English.
• Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation.
• Must demonstrate proficiencies with the quality systems.
• The ability to make pragmatic and compliant decisions.
• Strong result orientation and committed team member.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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