Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
Post: Senior General Manager / Associate Vice President
The jobholder looks after the planning, supervision, and execution of development activities for PROJECTS FOR ANDA/505 b2 and biologic FILINGS for US & EU markets.
· To Plan patent non-infringing developmental strategies for US/EU markets for products identified from time to time.
· To plan, and supervise pre-formulation, formulation, and process development activities related to the filings.
· To review and execute documentation related to product development and technology transfer.
· To provide assistance in liaison with Plant and Regulatory for product related activity
· To provide assistance in planning, and review of formulation Scale-up and technology transfer.
· To ensure compliance to cGMP and Standard Operating Procedures and maintenance and revision of SOP’s/ logbooks being utilized in all operational activities.
· To assist in Budget preparation, employee engagement, team development and planning and logistics
. Responsible for overseeing and managing a project schedule for the operations group including improvement, expansion and diversification projects.
. Responsible for providing direction for project lifecycle management and evaluating project planning, execution, performance, scope and providing regular reports on cost, schedule and risk.
. Communicates with business customers and management to provide reports on budget, cost, schedule, risk goals and priorities for projects.
. Provides technical expertise and support for the manufacturing and packaging operations.
. Develops project plans and identifies tracks and coordinates task between various functional areas to implement projects.
. Researches and analyzes data related to manufacturing and packaging operations to suggest improvements and promote efficiency.
. Generates and / or modifies standard operating procedures, batch records, special instructions and other related manufacturing and packaging documentation as specific to associated projects.
. Completes appropriate documentation to support project tracking, implementation and change management.
. Investigates, evaluates and recommends resolutions for manufacturing and packaging issues and implements resolutions.
. Initiates and facilitates cross-functional project meetings.
. Prepares project reports and summarizes project objectives, deliverables, status as required.
Minimum of a Masterr's degree (or equivalent) (Mpharm-Phd Preferred) and 12-16 years of project management, R&D manufacturing and/or packaging related experience. However, a combination of experience and/or education will be taken into consideration.
Must possess knowledge of cGMPs and SOPs applicable to position. 21CFR Part 210 and 211 and Part 11.
Knowledge and understanding of aseptic formulation, filling and packaging operations, equipment and facilities.
Basic knowledge of computer programs.
A background knowledge in pharmaceutical science or engineering is advantageous.
Must understand and adhere to Company and departmental policies and procedures.
SKILLS AND ABILITIES:
Must possess good interpersonal skills, effective verbal and written communication skills.
Must possess good problem solving skills.
Working knowledge of TrackWise, and Microsoft Office, including Word, Excel, Project and Lotus Notes.
Must demonstrate the ability to multi task by performing multiple projects and tasks simultaneously.
Experience: 12-16 years
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 21th March, 2013
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