Manufacturing Manager
Resume:
RAJESH M HORAGINAMANI
Somerset NJ -08873
*******@*****.***
____________________________________________________________________
Objective:
Seeking a full time manager/Sr.supervisor position in the field of manufacturing in a pharmaceutical
organization, which can utilize and enhance my management and interpersonal skills. Obtain a challenging,
rewarding, long-term position with significant potential for advancement that allows for innovation and an
opportunity to apply my versatile, adaptable, technical education, skill-sets, detail orientation, and
charismatic managerial expertise.
Profile
Profile
Over 12 Years of diversified professional experience in the field of pharmaceutical manufacturing, planning
and execution with good insight of brand and manufacturing techniques in Tablets, Hard Gelatin capsules
& Soft Gelatin capsules. Proven manager with strong manufacturing performance and demonstrated
leadership ability combined with extensive technical knowledge.,As Manufacturing Manager, demonstrated consistent improvement on performance and
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earned a reputation for delivering outstanding results regardless of environmental
challenges, and consistently met all efficiency targets.
Good at recruiting, training, compliance, planning & execution, team building, motivating &
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guiding the team to achieve desired targets. Good track record of manufacturing execution
that includes time and cost savings with successful results achieved by logical thinking and
knowledge of economics.
Ability to interact effectively with cross functional teams using excellent interpersonal skills
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and initiative to identify problems through analysis and demonstrated follow through on
implementing solutions.
Continuous effort to find effective ways to increase the production output & the quality, which
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requires intensive cooperation with a wide range of departments and disciplines both within
the company and outside of it.
Ability to motivate and direct employees to achieve high standards of quality and quantity.
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Demonstrated ability to use good judgment and make decisions.
Quantitative Achievements:
Implemented a procedure of recycling of the waste gelatin net generated during
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manufacturing and 32%-35% of the gelatin solution was recovered and reused.
A procedure known as De-aeration was implemented during manufacturing procedure of
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suspension products that resulted in increase of 20% batch yield (Actual yield increased from
75% to 95%).
Reduction of equipment down time from 30% to 15% was achieved by proper planning,
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utilizing the resources appropriately, economically and by training the employees.
Procedure to unload the gelatin solution using air pressure was implemented and manual
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unloading of gelatin solution was stopped that saved 6 man hours.
Composite sampling to determine the moisture content of dried capsules was implemented
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that saved 10 man hours.
Proper scheduling of the employees working hours resulted in avoiding the overtime payment
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and still production targets were met.
Implemented backup procedure for recording of environmental conditions in the drying rooms
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using calibrated data loggers that avoided incidents due to improper recording of
environmental conditions by Kaye system (main control system).
Procurement of double set of change parts for major equipment saved change over time by
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40%.
Core knowledge and skill areas include:
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Process simplification & redesign Planning systems development and cost control strategies
Operations improvement and contract manufacturing GMP guidelines and procedures.
Awards Received:
Recipient of “Best Employee of the Year” in 2005 from Strides Inc., USA
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Recipient of “Alumni Merit Award 2007” from KLE’s college of pharmacy, INDIA.
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.
Professional Experience Summary
Company: Sun pharmaceutical industries Inc., Cranbury, NJ 10/2008-Present
Designation: Manager – Manufacturing
Sun pharmaceutical industries Inc., is involved in commercial manufacturing of tablets and hard
gelatin capsules.
Key Responsibilities
Responsible for daily Production planning, execution follow up, training the employees, review and
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maintain production documents. Direct and support processes to ensure production schedules are
met. (Key metrics: Due date and schedule adherence, cycle time).
Responsible for developing individuals and teams to achieve expected performance standards and
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directing manufacturing functions.
Ensure smooth production processes, meet production schedules, and ensure consistent product
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quality while minimizing production costs.
Responsible for handling of manufacturing related Enterprise Resource Planning system (ERP)
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(creation of BOM, route, process route, process route instructions, work order, pick-up list…etc)
Responsible for the daily operations of manufacturing department to ensure the implementation of
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the manufacturing strategic goals by maximizing productivity through the optimal use of equipment
and personnel.
Involved in review of day to day manufacturing operations, identify the deviations and
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discrepancies. Directing the subordinates in the investigations/complaint investigations process in
order to identify the root cause and implement the corrective action and preventive actions. Monitor
the trends and effectiveness of individual CAPA.
Regularly identifies efforts and results by production team members and provides appropriate
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recognition. Responsible for conducting internal audit of the department and improving the systems
through cGMP compliance.
Responsible for initiating the investigation reports in the event of any unusual occurrence, change
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controls, planned deviations, cleaning validation/verification protocols, SOPs, and responsible for
review of quality documents.
Ensure that written procedures are being followed (GMP, batch record and company
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policies).Ensure that batch records are reviewed in a timely manner before they are submitted for
next unit operation.
Reviewing and approving the quality related documents such as Validation Master Plan, Cleaning
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Validation Master Plan, SOPs; Batch records; Operational & Performance Qualifications; Process &
Cleaning validations protocols, Change Requests & Planned Deviations.
Responsible for communicating measures for accountability to associates and assisting associates
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in meeting job responsibilities. Apply associate involvement methods as needed to increase
associate responsibility and ownership.
Responsible for training on cGMP, SOPs, Material handling, protocols, batch manufacturing
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records, investigations, change controls, incident report and deviations to supervisors and all other
employees.
• Coordinating with cross functional teams(Material Management, QC, QA, R&D) in order to meet the
production schedules and goals in timely manner.
Company: Pharmaceutics International Inc., Hunts Valley, MD 03/2008-10/2008
Designation: Manager – Manufacturing
PII is involved in contract manufacturing of clinical trial batches in the form of tablets, hard gelatin
capsules, suspensions, creams and soft gelatin capsules.
Key Responsibilities:
Based upon contract with the client, responsible for production planning, execution and
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responsible for over all manufacturing operations.
Involved in review of day to day manufacturing operations, identify the deviations and
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discrepancies. Directing the subordinates in the investigations/complaint investigations process in
order to identify the root cause and implement the corrective action and preventive actions. Monitor
the trends and effectiveness of individual CAPA.
As a successful Manager, ensured that risks or problems are identified, managed and mitigated.
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Projects were brought back on track whenever run into problems like running late or being way
over budget.
Trouble shooting and developing individuals and teams to achieve expected performance
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standards, directing manufacturing functions and initiating changes for improved products and.
Processes.
Co-ordinating with cross functional teams in order to meet the production schedules.
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Ensure that written procedures are being followed (GMP, batch record and company
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policies).Ensure that batch records are reviewed in a timely manner before they are submitted for
next unit operation.
W riting investigations in the event of any unusual occurrence to find the root cause and
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implementing corrective action and preventive actions and training the employees.
Identify the deviations and discrepancies. Directing the subordinates in the investigations/complaint
•
investigations process in order to identify the root cause and implement the corrective action and
preventive actions. Monitor the trends and effectiveness of individual CAPA.
Manufacturing strategic goals were implemented that lead to maximizing productivity through the
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optimal use of equipment and personnel.
Simplification of the operation procedures to save time & cost and still project targets were met as
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per the project plan.
Reviewing and approving the quality related documents such as Validation Master Plan, SOPs;
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Batch records; Operational & Performance Qualifications; Process & Cleaning validations, Change
Requests & Planned Deviations for the approval in order to meet the regulatory requirements.
Company: Strides Inc., Somerset, NJ Aug 2001-Feb 2008
Designation: Sr. Manager – Manufacturing
Strides Inc. was involved in manufacture of OTC, RX and dietary supplement products in the form of soft
gelatin capsules.
Key Responsibilities
Responsible for production planning (manufacturing and packaging), execution, training the
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employees, review and maintain production documents.
Direct and support processes to ensure production schedules are met. (Key metrics: Due date
•
and schedule adherence, cycle time).
Ensure smooth production processes, meet production schedules, and ensure consistent product
•
quality while minimizing production costs.
Responsible for the daily operations of manufacturing department to ensure the implementation of
•
the manufacturing strategic goals by maximizing productivity through the optimal use of equipment
and personnel.
Responsible for initiation of investigations and implementing the corrective actions and preventive
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actions, initiation of planned deviations, change controls, protocols, NOE (Notice of event), NCMR
(Non Confirming Material Report) related to manufacturing department.
Responsible for review of manufacturing documents like, batch manufacturing record, log books,
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Ssop (Sanitation Standard Operating Procedure -part of HACCP-Hazard Analysis and Critical
Control Point) execution in order to ensure that the execution is as per the procedures to meet the
regulatory requirements.
Support manufacturing in day-to-day troubleshooting situations and actively serve on IPT
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(Integrated Production Teams) as assigned.
During manufacturing, deviations and discrepancies are identified and justified scientifically,
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corrective actions and preventive actions are implemented.
Responsible for day to day manufacturing operations and directed the subordinates in the
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investigations/complaint investigations process in order to identify the root cause and implement
the corrective action and preventive actions. Monitor the trends and effectiveness of individual
CAPA.
Involved in 7 FDA, 3 DEA, 1 HACCP (Hazard Analysis and Critical Control Point) and various
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customer, vendor and internal audits.
Developing individuals and teams to achieve expected performance standards, directing
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manufacturing functions and initiating changes for improved products and processes.
Responsible for conducting the investigations in the event of any unusual occurrence in
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manufacturing department and Hiring of new employees required for manufacturing activities and
conducting the performance appraisal.
Company: Caryl Laboratories (Subsidiary of Strides) Feb1997- Aug 2001
Banagalore, India
Designation: Manufacturing Supervisor –Tablets and Hard Gelatin Capsules
Caryl Laboratories was involved in manufacture of Rx, OTC and dietary supplement products in form of
tablets and Hard gelatin capsules.
Key Responsibilities
Prepared manufacturing department Standard Operating Procedures (SOPs) and trained the
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employees.Ensuring that the SOPs and cGMPs are followed during all stages of manufacturing.
Based on planning, organized the manufacturing work by assigning the employees job
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responsibilities and set priorities in a detailed and thorough manner.
Checking the dispensed raw materials against the batch record for correctness of the dispensed
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material and updated the batch record, area cleaning logbook and equipment logbook prior to line
clearance activity. Initiated the line clearance to start the manufacturing activity.
Supervision of granulation activities like sieving of the raw materials, binder preparation,
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granulation, drying, sieving of the dried granules, milling of the dried granules, lubrication of the
dried granules and lubrication of the raw materials.
Inspection of the area and equipment cleanliness, issuance of the correct size & shape change
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parts for compression and encapsulation as specified in the batch record.
Updating the area cleaning logbook, batch record and equipment logbook prior to line clearance
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activity and initiation of line clearance for compression and encapsulation activity.
Ensuring the compression and encapsulation parameters are set as per the specifications
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mentioned in the batch record before commencing the manufacturing.
During compression, In-process checking of the parameters like weight variation, hardness,
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thickness, disintegration and friability to ensure that all the parameters are within the specification
as per batch record.
Trouble shooting of the problems during compression like weight variation, capping, picking,
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sticking, mottling and lamination of tablets.
During encapsulation, In-process checking of the parameters like weight variation, seal length and
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disintegration to ensure that all the parameters are within the specification as per batch record.
Trouble shooting of the problems during encapsulation like weight variation, improper seal length,
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alignment of the equipment.
Inspection of area and coating equipment cleanliness and updating the area cleaning logbook,
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batch record and coating equipment logbook. Initiation of line clearance for tablet coating activity
and supervision of coating solution preparation and documentation.
Supervision of tablet coating such as film coating, sugar coating and enteric coating and in-process
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checking of the coated tablets. In-process check of the coated tablets for weight gain and
disintegration test. Responsible for reconciliation and review of the batch record.
Handled various equipment like, rapid mixer granulator, fluidized bed drier, blenders, compression
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machines, Neocota, automatic and semi automatic encapsulation machines.
Education: Bachelor of pharmacy (1996) from Karnataka University, Dharwad, INDIA.
Pursuing Master of Business Administration (MBA)- I year, M K University, INDIA
Authorization to work in USA: Authorized to work in USA and no sponsorship is required.
References: Available upon request.
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