Position Summary :
Execution of production plan for sterile products with team of operators, supervisors working in three shifts.
Qualification of machine, periodic maintenance co-ordination.
Continuous improvement in productivity and Delivery time.
Work in close co-ordination with plant engineering head and warehouse head for execution of production, maintenance functions and related documentation.
cGMP compliance in the production area on 24x7 basis.
Co-ordination with QA, RND and PPIC for smooth functioning of production activities.
Imparting training, develop down the line skilled workforce and improve people and equipment efficiency.
Develop, Improve and implement SOPs, Batch records and other record formats relevant to plant.
Co-ordinate with R&D and PDL for tech transfer of new products and site transfer products.
Responsible for production execution and control of sterile products of liquid and lyophilized type
Responsible for man & material management in department.
Implementation and compliance of cGMPin manufacturing facility, which extend to basic functions of QA and microbiology lab also.
Authorisation of SOP, BPR, PR. Drawings or any other written documents.
Responsible for Plant Hygiene.
Responsible for Review and continuous up-gradation of SOP and other procedure related
Approval / Development of validation and qualification protocol
Manage Deviations, Change controls and CAPA
MIS and other report preparation
EHS compliance and Improvements
Education (degree / diploma) :
Preferably M. Pharm,or B.Pharmfrom reputed college. (Must be regular course only). BE or other equivalent / higher qualifications can be considered if rests of the requirements are highly suitable
Experience : 12+ Years in Sterile dosage forms, Including lyophilized product in reputed similar level organization. Experience in other dosage forms specifically Oral Solidsis advantage. At least 5 years of experience is at sites approved by FDA and/or MHRA.
Knowledge and Skills (Functional / Technical) : Handling of aseptic processes and equipment, utilities for aseptic products. Current regulatory expectations for sterile product supply to highly regulated market.
Qualification and Validation of pharmaceuticals.
ANDA batch executions.
Leadership / Managerial Attributes : Modest, Self-Confident, Initiator, Creative, Communicative, Responsible , trust
worthy, Decisive, Technical Competence, People Skills
Other requirements (licenses, certifications, specialized training) : GMP documentation skill, EHS knowledge, factory laws knowledge.
Computer : Proficient on MS Office, SAP and general computer applications. Good understanding of automated manufacturing process and its regulatory compliance.
Engineering knowledge : Basic knowledge of mechanical,Electrical and instrumentation engineering to effectively manage equipment operation and maintenance