Date PostedApril 6, 2023
Location (State / UT)
Experience5 Years, 11 Years
Desired QualificationBachelor Degree
Roles and Responsibilities:
- Responsible for reviewing the batch records of injectable products manufactured to ensure that they comply with regulatory requirements and company standards.Responsible for investigating any deviations or issues related to injectable products, including out-of-specification results, deviations from established procedures, and customer complaints.
Responsible for performing quality checks at various stages of the manufacturing process to ensure that the products meet the required specifications.
Ensuring that all aspects of the manufacturing process, including equipment, materials, procedures, and personnel, comply with regulatory requirements and company standards.
Desired Candidate Profile
- A bachelor’s or master’s degree in a relevant field such as pharmacy, chemistry, or biology.
- A minimum of 10-15 years of experience in quality assurance in the pharmaceutical industry, with a focus on injectable products.
- Strong knowledge of regulatory requirements and industry standards related to injectable products.
- Experience in developing, implementing, and maintaining quality assurance policies and procedures.
- Strong leadership and management skills, with the ability to manage a team and delegate responsibilities effectively.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Strong problem-solving and decision-making skills, with the ability to handle complex issues and implement corrective actions.
- Attention to detail and strong organizational skills, with the ability to manage multiple projects simultaneously.
- A commitment to continuous learning and professional development, with a willingness to keep up-to-date with industry developments.
- A positive and proactive approach, with the ability to work under pressure and meet deadlines.
Desired Candidate Profile
- Understanding regulatory requirements and guidelines such as cGMP, FDA, and ICH guidelines is necessary.
- Must be detail-oriented, able to identify and analyze issues and deviations, and have a strong focus on quality.
- Should have strong analytical skills, be able to interpret complex data, and make informed decisions.
- Should have excellent written and verbal communication skills, as they will be responsible for documenting and reporting on quality issues and deviations.
- Reviews the batch records to ensure that all required manufacturing and testing activities have been completed and that the product has been manufactured according to the approved manufacturing process.
- Ensures that all aspects of batch release comply with regulatory requirements and company standards.
Qualification: B. Pharma
Contact Person: Diljeet Singh