Title:  DGM - Operations (Sterile)

Job Role : DGM Operations (Sterile)

Education Qualification : B.Pharm, M.Pharm (Operations - Sterile)

Experience: 20 to 22 Years

Job Location : Halol

Job Responsibilities :

1.    Approving sign authority for:
-Commercial product/stability batches/ exhibit batches/ characterization 
-Batches-Master Batch manufacturing record and Master Batch Packaging record
-Risk assessment, process validation protocol, incident and investigation report, action, compliance and closure.
-CAPA Plans and closure.
-Protocols & reports.
-Internal Quality Audit/Regulatory Quality Audit Compliance and closure.
-Change control, standard operating procedure, Planned modification.
-Other quality documents including amendments.
2.    To assist the VP in batch manufacturing, packing and controlling the functions related of sterile manufacturing. To plan and execution of schedule as per work plan.
3.    Provide leadership and expertise to ensure achievement of production with respect to Quality and commercial demands.
4.    To ensuring that there are appropriate manufacturing and technical processes and procedures in place for the production.
5.    To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. The production records are evaluated and signed by a designated person.
6.    In coordination with Quality head monitor the factor that may affect product quality compliance of GMP, retention of records.
7.    To approve the instructions related to production operations, including the in-process controls, and to ensure their strict implementation.
8.    To check the maintenance of the department, premises and equipment.
9.    To ensure that the appropriate process validations and calibrations of control equipment are performed and recorded and the reports made available.
10.    To ensure that the required initial and contuining training of production personnel for SOP, CGMP, and personal hygiene like men, materials and machines in manufacturing and packing area.
11.    Optimization of the resources like men, materials and machines in manufacturing and packing area.
12.    Ensure efficient collaboration and coordination between relevant departments like warehouse, engineering, PPIC, quality control, Quality assurance, procurement and management.
13.    To coordinate with FDD/PDD(R&D) MSTG for execution of trail/exhibit/process validation batches and trouble shooting.
14.    Responsible for destruction of the rejected products as per SOP.
15.    Ensure implementation and adherence to Environment, health and safety procedures.
16.    Procurement of new suitable equipment’s required for process as per CGMP requirements.
17.    Identify and implement improvements to the production process, yield.
18.    Preparation and adherence to approved budget and manage expenditure and head count budget over the fiscal year.
19.    To ensure protection of the product from contamination. And monitor quality standards of products.
20.    Shall delegate authority to deputed deputies with satisfactory level of qualification and experience.
21.    Coach and develop direct and indirect reporters through on going, example based performance, feedback, annual performance reviews and provision of training and development opportunities.
22.    Assure all time readiness department for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams.
23.    Responsible for ensuring market complaints, failures deviations are investigated and corrective and preventive actions are implemented as per set timeline.
24.    Performs all work in support of our corporate values of pride-humility, integrity, passion and with accountability and diligence. Perform all work in accordance with all established regulatory and compliance and EHS requirements.