Analytical QA

3 weeks ago

Hyderabad, India Promea Therapeutics Full time

Full-Time Hyderabad 2-4 years

**Job Summary**:
The executive in Analytical Quality Assurance will be responsible for ensuring the quality and compliance of analytical testing processes and data in Promea. They will perform various quality assurance activities related to analytical methods, laboratory operations, and data integrity to support the development, manufacturing, and release of high-quality pharmaceutical products.

**Key Responsibilities**:

- Review and approve analytical method validation and transfer protocols, ensuring compliance with regulatory requirements and industry best practices.
- Provide guidance and support in the execution of analytical method validation and transfer activities.
- Review and approve analytical test results, ensuring accuracy, completeness, and compliance with established specifications and procedures.
- Perform investigations of out-of-specification (OOS) or out-of-trend (OOT) results and implement appropriate corrective and preventive actions (CAPAs).
- Ensure compliance with data integrity principles and Good Laboratory Practices (GLP) in analytical testing and documentation.
- Participate in the qualification and calibration of laboratory equipment, ensuring proper functioning and adherence to quality standards.
- Collaborate with cross-functional teams, including R&D, manufacturing, and quality control, to support analytical method development, optimization, and troubleshooting.
- Support regulatory inspections and audits by providing necessary documentation and assisting in addressing any quality-related findings or observations.
- Stay updated on current regulatory requirements, industry trends, and technological advancements in analytical testing and quality assurance.
- Assist in the development and improvement of Standard Operating Procedures (SOPs) and quality control documentation related to analytical quality assurance.

**Qualifications and Skills**:

- Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 2-5 years of experience in analytical quality assurance in the pharmaceutical industry.
- Strong knowledge of analytical techniques, such as HPLC, GC, dissolution testing, and spectroscopy.
- Familiarity with regulatory requirements related to analytical method validation, data integrity, and quality assurance.
- Experience in method validation and transfer activities, including protocol development and execution.
- Proficiency in laboratory quality control and quality assurance practices, including investigations, CAPA management, and change control.
- Understanding of Good Laboratory Practices (GLP) and laboratory compliance requirements.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong attention to detail and ability to work with complex data sets.
- Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
- Knowledge of laboratory equipment qualification and calibration processes.
- Familiarity with computerized systems used in analytical testing and data management.

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