Posted Jun 08, 2021 16 views
Responsibilities:
- Identify compliance issues and assist with Corrective and Preventive Actions (CAPAs), Employee Training and Documentation Control.
- Plan, conduct/coordinate GMP audits.
- Conduct the review/approval of validation documentation as per 21 CFR, Part 11;-Act as liaison between Quality, Purchasing and CMC in vendor selection and approval; Lead/contribute to area specific Regulatory Authority Inspections.
- Performs CMC supplier Quality Assessment visits, reporting and follow-up.
- Supports GMP activities and provides (project) quality oversight
- Contribute to and approves Quality Agreements between Client and relevant GMP vendors.
Qualifications:
- Bachelor’s Degree; 5-7 years’ experience in a Quality role, preferably within a biotech company.
- ASQ or equivalent Certified Auditor preferred.
- Knowledge of 21CFR Part 11 & OTS Validation.
- In-depth experience in development GMP- Proficient in GMP
- Knowledge of GXP.
Skills
Job Details
Systems Ltd
Systems Limited was established in 1977 as Pakistan's premier software house and technology based solution provider. Since its inception, it has grown and progressed to be at the center stage of information and technology, providing effective computing strategies and solutions to Private and Government Organizations. Systems Limited has played a major role in some of the largest IT projects in the country. Internationally, the Company has established itself as a key player in the critical market segments of United States, providing services & products to a growing list of corporate clients. Our diverse expertise extends beyond deployment to provide operational, maintenance, support and business outsourcing services. Our Technology Specialists have years of experience delivering successful solutions based on Microsoft, Oracle, IBM and Java-based technologies. Systems Limited is a fully employee-owned company representing a greater employee commitment to successful solution delivery. There are over 3000 professionals in our 5 offices in Pakistan,1 in India and 2 offices in United States.
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