A leading pharmaceutical company in Pune is seeking an experienced professional with 11 to 16 years in the industry. The role focuses on ensuring readiness of equipment, maintaining raw materials for batch execution, and preparing standard operating procedures (SOPs) for processing. Candidates should hold a Master's in Biotechnology or a Bachelor's in the relevant field. The ability to handle SAP activities and validate processes is a must.
Qualifications
11 to 16 years of experience in pharmaceutical manufacturing.
Proficient in preparation and execution of qualification protocols.
Experienced in handling process and maintenance via SAP.
Responsibilities
Ensure readiness of equipment and instruments for process.
Maintain availability of raw materials before batch execution.
Prepare, review, and execute process and equipment SOPs.
Skills
Equipment readiness
Process Raw materials handling
SOP Preparation and Review
Process validation protocols
SAP activities handling
Downstream equipment operation
Education
M.Sc. or B.Tech in Biotechnology or Biochemistry
Job description
Job Description
Ensure readiness of equipment and instrument for process.
Ensure availability of the process Raw materials, accessories and consumables in process area before batch execution.
Preparation, Review of process, equipment and area related SOPs and EOP's.
Preparation and execution of process, area and equipment qualification / validation protocols.
Preparation of various reports like process, equipment, area qualification and validation.
Preparation and Review of BPR.
Request and Issuance of BPR.
Preparation, Review and execution of study protocols.
Readiness of downstream area and other areas like corridors and washing area etc. for manufacturing operations.
To ensure smooth functioning of shop floor functions during manufacturing campaigns, and to raise and review change control and deviations as per the requirement.
Handling of SAP related activities like process and maintenance.
Operating downstream equipment's for process and CIP/SIP.