Responsibilities
Ensure the smooth and effective functioning of the production department.
Ensure proper maintenance of production equipment and coordinate its installation and qualification.
Ensure the timely preparation, initiation, and review of departmental SOPs.
Ensure the timely closure of change controls and deviations.
Provide necessary training to production personnel on an ongoing basis.
Ensure the timely completion of batch documents, including MPCR-I and MPCR-II.
Supervise production operations effectively and efficiently.
Coordinate with QA to conduct self-inspections and address audit observations.
Foster a collaborative team setting within the department and resolve issues in coordination with Quality Management.
Coordinate with the warehouse for the issuance of materials and ensure adherence to the production schedule.
Ensure adherence to positive documentation practices and the recording of production activities at the time they are performed.
Skills
The candidate should have relevant experience in the pharmaceutical industry, preferably in Oral Solid Formulations, with regulatory exposure to USFDA, MHRA, EU, TGA, etc.
The candidate should demonstrate leadership, teamwork, problem-solving ability, analytical thinking, and excellent verbal and written communication skills.