QA Specialist

Title

(Senior) QA Specialist

Department

BioVV APAC

Report to

QA Manager

Location

Shanghai

This position is responsible for the management of quality operation of GMP Facility and Biodevelopment Lab, to ensure the operation meeting the quality requirements from customer, cooperate and regulatory. The position also focuses on establishment and improving quality culture in GMP Facility and Biodevelopment Lab.

Internal to BioVV APAC: work in liaison with all operation teams of GMP Facility and other quality team members.

External to BioVV APAC:

Within  group, work with other necessary teams including but not limited to regulatory, quality teams of other functions and overseas global quality teams.

Outside  group: collaborate with customers, regulatory authorities and suppliers, if necessary.

Management of deviation, change control and CAPA to guarantee the compliance and effectiveness of the procedures

• Cooperate with other teams on necessary assessment, investigations, planning, action definition and follow up.
• Work as coordinator in TrackWise to follow up execution of deviation, change control or CAPA.
• Maintain tables and draft annual report if necessary.

Act as production or development counterpart to give quality support on daily operations

• Communicate with operation teams regularly and align operation priorities with quality considerations.
• Provide quality guidance to ensure operations are in compliant with quality requirements.
• Discover opportunities for improvement and detect events will potentially harm the benefits of BioVV APAC.

Storage management of drug substance, cell banks and retention samples

• Maintain tables and perform regular stock check with operation team.

Provide regulatory support in field of quality system and quality operation as per the request of customer or colleagues

Lead and act as the Subject Matter Expert of quality system and quality operation for audits and client communication

Accomplish other tasks assigned by line manager

Respect and follow EHS rules

Autonomy:

• Autonomy in the daily quality operations management of GMP Facility and Biodevelopment Lab within defined responsibility.

Can be replaced:

• Completely by QA Manager.
• Partially by a peer Senior QA Specialist or QA Specialist.

Can replace:

• Partially of the QA Manager on quality topics.
• Partially by a Senior QA Specialist or QA Specialist.

Education

• Bachelor’s degree or above;
• Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds

Experience

• 3-8 years+ of working experience in pharmaceutical, bio-pharmaceutical or life science industry
• 2-5 years+ working experience of quality related fields (e.g. QA, etc.)
• 5 years+ working experience in GMP or GLP environment is a plus
• Ability of regulatory precipitation
• Knowledge of antibody production process is a plus
• Successful project participation experience of establishing PD/GMP QMS, C&Q or NMPA/FDA/EMEA GMP certification
• Participation experience of customer project

Language Skill

• CET 6 or equivalent certification of English
• Fluent English reading and writing
• Fluent English speaking is a plus