Job Description

Work Schedule

Flex 12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

The incumbent willassistmanagerto supervise a team to meet production targets/schedules while alwaysmaintainingstandards of cGMP, safety, and housekeeping Along withthisthe incumbent willperform various tasks and activities listed below for which they are appropriately trained andare in compliance withthe cGMP, company and department SOPs and the safety regulations.

Responsibilities

• Monitor the production activities and ensure that processes areperformingas per process description and SOPs. Responsible to complete batch documentation accurately and thoroughly, while adhering to the quality and safety standards, andmaintaininga productive, cost-effective process.

• Assist the Production Leader in the day-day production activities. Approve the required production cycles.

• Assistand ensureoptimumallocation of personnel and equipment. Liaison with associated departments for day-day issues.

• Report andassistto investigatequality deviationsAssistin troubleshooting of relatedquality deviationsand resolving problems that arise during the processing.

• Ensure correctness of completed batch sheets and thetimelysubmission of the same.

• Ensure adherence tocGMPand GDP (Good Documentation Practice).

• Approve and closeoutsafetyworkpermit

• Attend team meetings and other meetings asrequired

• Provide oversight during preventive and breakdown maintenance. This includes providing Operations oversight of CMPMCalibrationactivities in the production area.

• Lead Continuous Improvementactivities asassigned bymanagerto improve Quality as well as Efficiency.

• If required, setup and operate pharmaceutical production equipment including high-speed filling lines for sterile products, fully automaticLyophilizser, Autoclave, parts and vial washers,depyrogenationtunnel, Formulation process, HMI and automatic CIP/SIP processes and inspection and packaging line equipment (e.g. AVIM, labelling and carton machine etc.) as per relevant SOPs and theBatch Record

• If required, performformulation activities of production batches as per relevant SOPs and theBatch RecordThis includes formulation and/or dispensing of all the available Drug substance(s) and excipients.

• Complete all the relevant training before executing any task all the time and every time.

• Responsible to perform all the materials and process (SAP) transactions at each manufacturing process steps as perrelevant SOPs and theBatch Record

• For aseptic operations strictly follow aseptic techniques and practices practiceas per relevant SOPs.

• If required, carry out the cleaningand upkeep ofthe production equipment and classified areas in manufacturing areaas per relevant SOPs and theBatch Record

• If required, perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing (e.g.bioburden sampling, waler sampling). If applicable, perform chemical and physical tests during the processing of the batch (e.g.pH testing).

• If required, prepare filters for test executionand perform FIT (filter Integrity testing)as per relevant SOPs and theBatch Record

• Follow safety and quality compliance at all timesand communicatein a timely mannerto the superior if any anomalies areobserved

• Participate in EHS, Business Compliance,cGMPand all other compliance-related matters, where applicable

• Perform all tasksin accordance withthe standard operating procedures andmaintainstrict compliancetoGMP at all times.Report all the quality issuesimmediatelytoManageror Lead technician

• If required and depending on product requirement, perform chemical and mathematical calculations todetermineproduct potency and endotoxin levels for eachbatchformulation.

• Any other duties as and when assigned by the Manager

How will you get here?

Education

• Minimum“O” Level, NITEC/ITEeducation/Diploma in relevant field.

Experience

• Minimum5years of relevant experiences in pharmaceutical industry.

Knowledge, Skills, Abilities

• Good understanding of safe working practices and cGMP.

• Highly motivated to work in pharmaceutical Industry.

• Able to work as a team.

• Able to work rotating shift.