Position
:Sr. Manager-Quality Assurance
Qualification : MSc [Microbiology/Biotechnology) or M Pharm/B pharm
Over All Experience :
• Have experience of leading the QA function of sterile/injectable site (s) including IPQA, Product Release,
QMS, Audit and Documentation Management Validation & Qualification and Investigation. • Direct handling of audits from either of USFDA/MHRA/EU GMP agencies.
• Total experience shall be 15 Years or above.
Reporting to: Site QA Head
Location : Plant, Nalagarh
KEY FUNCTION/RESPONSIBILITIES
Technical experience & expertise:
• Have in-depth knowledge of aseptic manufacturing operations and associated risks. • Well verse with following requirements and shall have experience of directly leading the respective QA functions/teams for sterile/injectable site (s):
Facility qualifications and controls required for management of classified areas, storage areas and water system.
> Product sterilization concepts.
In-process controls for the product compounding, filtration and filling operations. Packing operations including serialization.
Process validations, cleaning validations, process simulations and continuous process monitoring.
> Product release.
Have good experience of performing & leading the investigations specifically related to the:
Production & engineering deviations. Sterility assurance and media fills
Phase Il investigations for analytical and stability out of specifications.
Market complaints.
Shall have thorough understanding of USFDA, MHRA, EU GMP, Russia GMP and Ukrainian GMP guidelines and requirements for a sterile/injectable site specifically above stated activities. Leadership experience & expertise:
Have led the team/site in development of "Quality Culture" specifically related to the implementation
> Data integrity, security and controls.
> Effective review system.
Technical writing skills.
Lean processes.
Effective in-process controls.
Training program management. Have implemented effective CAPA identification and implementation system, change management
system and quality risk management system. Production & engineering deviations.
Sterility assurance and media fills
