Responsible for planning and coordinating the development and commercial efforts of Pharmaceutical products, collaborating on marketing strategies to include the development of sales, and promotional campaigns for new and existing products.
The incumbent will primarily be responsible for working within a team to lead and execute change control assessments, planning, tracking, authoring, reviewing and gaining approval for global post approval changes, and may assist in developing regulatory strategies.
The professional must organize, direct and manage all aspects of the manufacturing departmental operations (through direct and indirect reports) to ensure the products produced meet quality standard, cost and on time schedule. The ideal candidate will interface with client contacts in a professional, service oriented manner to foster excellence and achievement of client goals and objectives.
Ensure compliance with protocols, company procedure and cGMP standards This Quality Control Laboratory conducts analytical testing of APIs , excipients , components, finished drug product, validation testing ,stability testing and method transfer. The ideal candidate will have an understanding of cGMP and Quality Systems as well as good organizational skills, self-motivation, and the ability to work in a team.
The Quality Assurance Specialist is an experienced professional with extensive QA involvement in the Pharmaceutical Industry. This position is primarily responsible for planning, developing, implementing, and maintaining an efficient quality system to comply with company policies, regulatory requirements, quality standards, reporting requirements, and applicable laws.