Company:
A leading organization in the pharmaceutical manufacturing sector dedicated to ensuring the highest standards of quality and safety in production. The company focuses on delivering innovative solutions within a regulated environment, adhering to strict GMP guidelines and continuous improvement initiatives.
Job Description:
The Quality Assurance Production Specialist is responsible for overseeing and supporting pharmaceutical production processes to ensure compliance with quality standards. This role involves evaluating production activities, supporting quality improvement projects, and maintaining strict adherence to GMP regulations.
Responsibilities:
-Ensure quality assurance within pharmaceutical production, including bulk manufacturing and packaging operations.
-Support production teams in managing deviations and quality issues, including deciding whether to halt production if necessary.
-Propose and implement improvements to manufacturing processes and technology.
-Provide technical and content support regarding quality matters, including monitoring, investigating, and documenting deviations and complaints.
-Conduct root cause analyses and develop corrective and preventive actions (CAPAs).
-Lead initiatives for process improvements stemming from audits, deviations, or continuous improvement programs.
-Advise on occupational health and safety, product safety, and environmental policies.
-Participate in audits, investigations, and compliance responses.
-Maintain up-to-date documentation, including SOP reviews, validation protocols, and batch records.
-Contribute to project work, change controls, and staff training efforts.
-Engage in business unit meetings and collaborations with internal and external stakeholders.
Requirements:
-Master’s degree or equivalent in Pharmacy, Chemical Engineering, or a related field.
-Knowledge of aseptic pharmaceutical processes and production control systems.
-Experience working within pharmaceutical manufacturing environments.
-Strong communication, analytical, planning, and reporting skills.
-Proficiency in English, both spoken and written.
-Ability to thrive in a dynamic, regulated setting with attention to detail and quality.
-Skills in training, knowledge transfer, and teamwork.
Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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Neetu Parkala
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