SOP on Responsibilities – Senior Production Chemist
1.0 Purpose: This SOP describes the basic responsibilities of Sr. Production Chemist
2.0 Scope: This SOP applies to Sr. Production Chemist.
3.0 Responsibility: Production Director to ensure that procedure is followed.
4.0 Materials and Equipment: None
5.0 Procedure: Senior Production Chemist Responsibilities
5.01 It is the responsibility of Senior Production Chemist to ensure maintenance of premises, department and equipment are in compliance with Govt. regulations & GMP requirement.
5.02 It is the responsibility of Senior Production Chemist to approve instructions related to production operations and their implementation.
5.03 It is the responsibility of Senior Production Chemist to ensure that production records are evaluated by an authorized person before they are made available to Quality Control Laboratory.
5.04 It is the responsibility of Senior Production Chemist to ensure that all products are produced and stored according to an appropriate documentation.
5.05 It is the responsibility of Senior Production Chemist to ensure that processing equipment are calibrated and records are maintained.
5.06 It is the responsibility of Senior Production Chemist to ensure that all processes are validated and their records are maintained.
5.07 It is the responsibility of Senior Production Chemist to ensure initial and continuing training of production personnel, relevant to their needs.
5.08 It is the responsibility of Senior Production Chemist to ensure maintenance of plant hygiene, monitoring and control of environment of production areas.
5.09 It is the responsibility of Senior Production Chemist to ensure that records are retained for periods specified by the national regulatory authorities and records are easily available whenever required.
5.10 It is the responsibility of Senior Production Chemist for production planning and completion of jobs within specified limits.
5.11 It is the responsibility of Senior Production Chemist to directly report to Managing Director for compliance of GMP.
5.12 It is the responsibility of Senior Production Chemist to check all written SOPs and other documents related to production activities.