Senior Executive

Purpose  This candidate will primarily be responsible for supervision of shop floor activities of Nasal Manufacturing, filling, Autoclaving and packing activities in shifts with close monitoring of throughput along with quality compliance   & efficiency in GMP environment.  Position / Job Title  Sr. Executive  Department  Nasal Formulation  Reporting To  Asst. Manager / Manager  Location  Ambernath  Years of Experience  7+ Years  Dosage Form  Nasal Formulation   

Job Responsibilities / Deliverables

To Perform & monitor the shopfloor Activities in 3 shifts.
Prepare weekly and monthly schedule as per demand received from SCM Team.
Responsible for achieving targeted shift output with highest quality of product.
To allocate the manpower in respective areas and should have experience in manpower handling.
Supervision of area cleaning, sanitization, equipment cleaning, batch manufacturing, batch filling, batch packing and autoclaving activities & Online recording of the activity in the BMR/BPR and Logbooks.
Troubleshooting of equipment by coordination with machine technician & engineering and vendor if major issue.
Monitors rejection and ensures minimal rejections and losses during the filtration, filling and packing operations and track the same.
Prepare training matrix and complete the all required training as per TNID.
Timely submission of qualification documents, BMR's BPR's, Validation reports etc.
To carry out the qualification and any modification activities and complete timely manner.
To ensure safety, hygiene and maintain c-GMP environment during manufacturing, filling, autoclaving and packing process.
To give daily production report and submit completed BPR to Department Head including posting of entries in SAP.
To check calibration of balances/instruments and preventive maintenance of equipment's.
Reporting of the incidence, handling of the deviation and change control.
Ensure new machine qualifications are carried out as per standard procedures.
Provide ideas for process optimization and cycle time reduction.

Qualifications & Pre-Requisites

B. Pharm
Total experience of 7+ years in supervisory role at Nasal formulation/Oral liquids/ophthalmic formulation.
Should have good experience in operation of 21 CFR part 11 compliant system and have knowledge of performing CIP, SIP, Pressure hold test and recipe base manufacturing.
Should have good experience in operation of manufacturing and holding equipment preferably Biozeen/Gem pharm/Adam/Praj Hi purity/Anish pharma/DD pharma/life craft / Groninger / Strobel / ROTA / Blister / Cartonator.
Candidates can be hired preferably from Cipla / Glenmark / Aurobindo / Dr. Reddy's / Indoco Remedies / Accent Pharma / Gland / Caplin Point / Lupin / Serum.

Additional notes

Role is expected to work in all shifts.
Exposure of regulatory audits
-USFDA, MHRA, TGA, ANVISA etc.