| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Oil & Gas Jobs |
| Banking Jobs |
| Construction Jobs |
| Top Management Jobs |
| IT - Software Jobs |
| Medical Healthcare Jobs |
| Purchase / Logistics Jobs |
| Sales |
| Ajax Jobs |
| Designing Jobs |
| ASP .NET Jobs |
| Java Jobs |
| MySQL Jobs |
| Sap hr Jobs |
| Software Testing Jobs |
| Html Jobs |
| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
10 - 15 years of experience as a Quality Control professional in the pharmaceutical manufacturing industry (Formulation / finished drug product), with a minimum five to seven years in managerial / leadership positions. To strengthen and maintain the quality systems in QC laboratory to meet the regulatory requirements. Sound exposure to face regulatory audit like EU, MHRA, TGA, MCC, ROW etc. Demonstrated Lean experience and understanding. Hands on experience in Europe & Australia region. Responsible for review of laboratory log books, formats, analytical data sheets as per GDP. Responsible for method transfer and method validations, timely release of samples as per production schedule. To review and evaluate analytical records and subsequent approvals or rejection of starting materials, packaging materials, intermediates, bulk and finished products. Advanced knowledge of cGMP requirements, quality systems, applicable to the QC Operations Demonstrated management skills; ability to influence and engage direct and indirect reports and peers. Strong written, oral, interpersonal, and presentation skills and the ability to effectively interface with all levels of management and staff. To approve specifications, sampling instructions, STP, analytical records and COA. To responsible for review and to ensure routine and periodic calibration, preventive maintenance and qualification of instruments, equipments of the plant.Responsible for preparation of protocols and reports related to qualification and re-qualification of instruments and their execution. Responsible for review of calibration procedures to be in line with current pharmacopeia/guidelines. Responsible for providing the troubleshooting support to analysts To conduct cGMP and cGLP training programmes. To ensure compliance for various GMP / GLP monitoring tools like internal quality audits, in process testing etc. To carry out active participation in the Regulatory audits, external and internal audits of Quality Control. To ensure adherence to Good Laboratory Practices in Quality Control Lab. 1. Excellent verbal and written communication skills 2. Able to effectively communicate with internal and external customers 3. Effective communication with the cross functions. 4. Must be able to meet deadline with a positive attitude and atmosphere 5. Able to withstand work pressure at situation and manage the tasks to resolve the situation Managerial skills 1. Exceptionally professional, organized and detail oriented 2. Experienced in management of team comparison more than 10-15 people. 3. Leadership qualities to educate and develop the team 4. Good relationship with the team, keeping the organizational goal as the primary motive 5. Able adopt to the culture and norms of the organization and enforce the same to the team 6. Training the team in technical and other soft skills as required ,
Keyskills :
gmpstpglpmcctgaleancgmpmhratestingcglpsoundcontrol