Equipment Qualification, QA Officer, CAPA, incident, deviation.

CURRICULUM VITAE

LOVISH

S/O BALDEV SINGH

RESIDENCE::- 349, SECTOR 19, PANCHKULA- HARYANA

MOBILE- 988-***-****

E-MAIL: *****.***********@*****.***

OBJECTIVE

To work in a professional and result oriented environment, look for continuous growth and learning opportunities, preferably in a progressive and competitive work culture in a research driven company and contribute to pharmaceutical Industry. DESCRIPTION OF MY PERFECT JOB: An organization that provides on going personal development. It is important to have a stimulating workplace, and to keep progressing as an organization.

Professional Experience (2.5 years)

Currently working in Quality Assurance department as an OFFICER at Acme Generics

(EU-GMP Hungary, TGA Australia, USA Approved for FDA 21 CFR Compliance for Manufacturing and Dietary supplements.) -Baddi, Dist. solan (H.P), since Sep- 2019 to till Date.

Worked in Production department as Production OFFICER at Theon Pharmaceuticals Limited, Saini majra,Nalagarh, Dist. solan (H.P), since Feb- 2018 to Sep-2019. Responsibilities

Since Sep-19: Current job responsibilities at Acme Generics as Officer Quality Assurance

● Responsible for the monitor, review and assessment of Quality management system (like change control, deviation, incident, market complaint).

● Responsible for the timely updating of the documents in line with the current regulatory guidelines.

● Responsible for Assistance during Equipment Qualification.

● Preparing monthly QMS report of department and presenting to the functional head QA.

● In-process quality assurance checks at various stages of Tablet formulation like granulation, Compression and Coating.

● To give line clearance at every step of batch.

● Routine trouble shooting during day to day manufacturing.

● Verification and control of production activities and in process Quality checks at shop floor of Tablets, Capsules, ointment and dry syrup in accordance with cGMP norms.

● Managed IPQC of Tablets, Capsules, Sachets and Ointment.

● To Observe and documented the non-compliance & deviations on the shop floor.

● Implementation of CAPA based on the investigation findings and verification of its effectiveness.

● Actively involved in to maintain weekly IPQA monitoring & GMP behavior round.

● Calibrated the equipment of IPQA lab

● Completion of documents including batch records & other documents like log books.

● Verified manufacturing & packing operations on the shop floor.

● Review of executed BMR & BPR.

● Maintain proper communication with other ancillary department like Production, QC, Engineering and warehouses etc.

● Proper training on SOP (standard operating procedures) and cGMP (current good manufacturing practices) guideline to manpower like machine operator & Subordinates to obtaining required skill and perform their duties.

● To involve in validation of product and introduction of new formulation through technology transfer.

Feb-2018 –Sep.2019: Responsibilities in previous Employer: Theon Pharmaceutical Limited as Production Officer.

Supervision and control of production activities and in process Quality checks at shop floor of Tablets, Capsules, ointment and dry syrup in accordance with cGMP norms.

Handling and operating of IPQC instruments like D.T. apparatus, Analytical balance, Friability apparatus (ROCHE), Leak test apparatus, Hardness tester (MONSANTO, PFYZER, CAMPBELL etc).

Man power handling, target achievements and allocation of daily work to manpower.

Having JD ORACLE (systems application & processing of data management) knowledge related to production.

Daily Planning, Production, Handling and Arrangement of material.

To complete production schedule as per planning with quality and optimum utilization of resources.

Maintain proper communication with other ancillary department like QA, QC, Engineering, Store and warehouses etc.

Proper handling and maintaining of Primary & Secondary Packing materials.

Online documentation like BMRs, BPRs & log cards.

Proper training on SOP (standard operating procedures) and cGMP (current good manufacturing practices) guideline to manpower like machine operator & Subordinates to obtaining required skill and perform their duties.

To ensure and maintain % yield & productivity as per standards & to work actively for further enhancing the yield and productivity.

Preparation of daily production report, OPMD (output per man per day) report and Monthly WIP (Work in Process) report.

To involve in validation of product and introduction of new formulation through technology transfer.

Handling of production related deviations and change control.

Handling of Training records.

Areas of Strength

Handling of Change control.

Handling of Deviation, incident and Investigations.

Equipment Qualification

Compression of tablets (D and B tooling ), 43,55,45, & 61 Station (CADMACH) SpecialPTK 43 station, tablet in tablet compression machine, filling of capsules

(semi automatic hand filling ) etc.

Compression of tablets 75 & 81 Station (ELIZA PRESS)

Ointment (manufacturing, tube filling, packing.)

Dry syrup (filling, labeling and packing)

Coating (enteric, film and sugar coating) of tablets.

Primary packing (ALU-ALU BLISTER RAPID PACK 2MP, SATELLITE ENGINEERING STRIP MACHINE, ELEMACH BLISTER, RAPID PACK BLISTER)

Handling of JD oracle related work.

Academic Qualifications

Bachelor in Pharmacy from SWAMI VIVEKANAND COLLEGE OF PHARMACY

(PTU) with aggregate of 55%.

Completed Intermediate with 60.0% from G.M. S.S.S sector 8 chandigarh CBSC board.

Completed High School with 7.6 CGPA from Kendriya Vidhyalaya Zirakpur, Mohali. AUDIT FACED SUCCESSFULLY:

Regulatory Audits:

● PPB KENYA :- 2019

● PIC/S :- 2018

● SBS Yemen :- 2019

Costumer audits:

● Cipla, Lupin, Abott, Emcure, Sun Pharma, Wockhardt, Zydus, Glenmark., GSK, Dr.Reddy’s, Indoco Remedies, Mankind etc.

COMPUTER PROFICIENCY

Knowledge of Internet.

Basic knowledge of M.S Office.

SPECIALITY

● Excellent communication skills and an ability to relate to people at any level of management.

● Possessing valuable insights, keen analysis and team approach to achieve business excellence.

● Adapt at working in high pressure environments with strict deadlines & multiple deliverables.

● Great inter-personal skills and comfortable working effectiveness both independently and in team atmosphere.

● Immense flexibility of handling a variety of tasks and shifts priorities simultaneously.

● Excellent decision-making skills with a positive approach, friendly with an upbeat attitude.

PERSONEL VITAE

Date of Birth : 02 April 1995

Gender: Male

Nationality: Indian

Marital Status: Single

Languages: English, hindi, punjabi.

DECLARATION

I solemnly declare that the above information is true and correct to the best of my knowledge and belief.

(LOVISH)

*****.***********@*****.***

Mobile no.: 988-***-****

Contact this candidate