SAMIEA MASOOD RAJPUT

**** ***** ***** **** ********** 213 Austin TX 78753 Cell Number: 737-***-**** E-mail: ac0a2h@r.postjobfree.com

PROFILE

5+ years of experience in pharmaceutical manufacturing, quality, compliance & lean manufacturing.

Proficient in track wise, SAP, outlook, Microsoft Office, Minitab & other instrument based software.

Strong understanding of Production, Quality & compliance experience of Pharmaceutical products.

Solid understanding of Deviation, Change control, Documentation & batch record.

Strong ability to lead Root cause Analysis & managing change control with multifunctional group support.

Strong knowledge of GMP, USDA / FDA / OSHA regulations.

Proven ability to manage multiple assignments independently under minimum supervision with tight deadlines.

Possess strong task planning, thinking, problem solving & decision making skills.

Quick learner & easy adaptability of new system & methods.

Excellent interpersonal skills & communication skills in working with all level staff.

AWARDS

OEE award (Overall Equipment Efficiency) Bronze Award for Semi solid Packaging Line.

OEE award (Overall Equipment Efficiency) Bronze Award for Solid Oral Packaging Line.

OEE award (Overall Equipment Efficiency) Bronze Award for Liquid Packaging Manual Line.

OEE award (Overall Equipment Efficiency) Bronze Award for Liquid Packaging Auto Line.

OEE award (Overall Equipment Efficiency) Silver Award for Liquid Packaging Manual Line.

OEE award (Overall Equipment Efficiency) Silver Award for Liquid Packaging Auto Line.

Best Quality Board Award

Award for highest Number Of ZAP (Zero Accident Promotion)

Award for the Highest Production Of the year.

PROFESSIONAL EXPERIENCE

AS PRODUCTION LEAD (GSK & NOVARTIS CONSUMER HEALTH From June 2011-JAN 2017)

Manage, Control and Lead the overall Manufacturing & Packaging process of Solid Oral, Syrup & Semi-Solids Production.

Ensure tasks are performed according to standard procedures and regulations.

Investigate and resolve production and personnel issues as they arise.

Ensure SAP batch control of raw material & Packing material.

Prepare and submit data for production reporting & ensure accurate timekeeping.

Ensure proper labor utilization & Conduct regular staff meetings.

Perform and report on accident investigations.

Maintain high state of cleanliness & reconcile daily down-time on production line. .

Follow & ensure following the established procedures and guidelines as per EHS & Quality to manufacture products according to production specifications and schedules.

Ensure timely update, revise, review prepare & approve all PIs, MIs & SOPs of department in order to avoid overdue situations.

Check and ensure changeover / Line Clearance of machines in an effective manner.

Raise and support to timely closure of CAPA & its execution.

Ensure material receiving, returning & verification, equipment installation, cleaning & operations, area cleaning & verification, environmental monitoring are as per procedure & SOPs.

Properly archiving of documents according to local SOP.

Ensure proper implementation of LOTO, working at height, hot work permit, confined space, wet floor & other safety related work in the related department.

Ensure the proper waste management of the department as per local SOP.

Ensure timely delivery of Export Orders.

Assigned appropriate manufacturing supervisor, assembler and operator duties.

Monitoring the production processes and adjusting schedules as needed.

Being responsible for the selection and maintenance of equipment.

Ensure & maintain the availability of all assets.

As Area Continuous Improvement Associate

To design and direct a continuous improvement process throughout all facility by using

Lean & Six Sigma tool sets

5s, TPM (total productive maintenance), AM (autonomous maintenance) & Kaizen

Developing and delivering CILT training programs for the manufacturing area.

Developing measuring systems throughout the facility by calculating OEE.

Implement Visual Performance Management through signs & indications.

Implement Best Practices including, process improvement, capacity expansion projects, yield improvement, manpower utilization, overhead spend, capital utilization, indirect spend, factory utilization, factory efficiency, work capital both raw material and finished goods & cost reduction projects.

Coordinate major initiatives across the supply chain to insure optimum cost including large-scale trials; working with processing and packaging operators to execute trial demands.

AS SITE TRAINER

Identifying training needs & ensuring training of the associates & maintaining of their records.

Responsible for implementing training and curriculum development as it pertains to professional development training programs.

Responsible for administration of employee and training, including evaluating training needs, revising current course material, creating new content, and reviewing course feedback and implementing changes as needed in HR ordination.

Responsible to tracking and Analysis of training metrics and trends to enhance performance in HR coordination.

Assist with individual/team assessment and evaluation.

As A Quality Compliance Team Associate

Triage all received complaints in order to immediately identify any potentially expedited quality/compliance issues.

Responsible for recording quality complaint information received into the global complaint database.

Determine when a complaint sample should be retrieved for evaluation.

Issue response letters to complainants regarding product complaints received.

Contact reporter, as necessary, to gather additional complaint information to ensure the site may adequately evaluate the alleged complaint.

Investigate product complaints on manufacturing floor & Interview relevant associates for actual root cause.

As QC Analyst (Zantok Pharma –Pakistan JAN2011-MAY2011)

Maintain departmental documentation including, local checklists, logbooks, etc.

Responsible for cGMP compliance and inspection of labs. Review and approval of documentation associated with method validations, investigations, change controls, regulatory filings, technical reports and technical memos.

Perform chemical, physical & analytical testing of raw materials, bulk intermediate and finished products, validations/qualification, characterization work and projects.

Oversee and guide lab analysts on continuous improvements tools including implementation of new technologies to department goals and objectives.

Support in process validation testing, testing in support of investigations, method validation/qualification/verification activities, qualification of in-house reference standards, lab compliance and meeting customer timelines.

Calibrate, validate, or maintain laboratory equipment.

EDUCATION

Pharm D (Doctor of Pharmacy)

Federal Urdu university of arts, science & technology-2010

CERTIFICATION

Registered Degree from Pharmacy Council Sindh-Pakistan

Certified as site Certified Trained the Trainer.

Generating GMP documentation, Record Management & data integrity

Certified complaint & deviation investigator.

Documentation Handling of signatures(electronic & manual)

Record retention & archiving

Change control management

TPM(Total Productive Maintenance)

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