Executive Profile

Result-oriented professional (Microbiologist) with an experience of over 17 years in the Sterile Formulation/API Pharmaceutical industry, Brown field Projects.

Aseptic techniques, regulatory compliance, analytical quality assurance, People management, equipment/classified area qualification, capacity mapping, Validation of Microbiological tests and execution. Review of Cleaning, Process validation protocols and qualification protocols of facilities, utilities.

Proven capabilities in maintenance of entire microbiology Operations with advanced microbiological techniques, instruments with controlled cost and in line with business requirements.

Exposure on successful completion of major audits like USFDA-3times, M.H.R.A-1 time, T.G.A, ANVISA audits.

Expertise in planning and implementation of changes to Microbiology process, Procedures, Lab systems, environmental monitoring program and testing methods with appropriate CAPA and quality system adherence .

Utilized available manpower, equipment, material resources to maximize the Efficiency.

Skilled in implementing operational excellence techniques, namely IMEX, Quality Circles,5S and continuous improvement concepts etc

Rendered services as key lead role for implementing Sterility assurance program with microbiology concepts in aseptic monitoring techniques per regulatory requirements.

Notable Accomplishments Across The Career

At Pfizer

Group Lead - Testing & Media/Lab support team management

Ensuring Compliance of entire group per Pfizer quality standards and regulatory requirement.

Coordination with Global quality team for identifying GAPS in Procedures, Process and evaluation of them.

Participating in batch planning meetings and ensuring timely testing and release of reports to the batch release team.

Guiding the team leads for fixing the issues and providing solution for completion of impacted process.

Successfully achieved 5S certification of Microbiology lab.

Process simplification projects: 1.Successfully removed the Incubator/Autoclave printout process and implemented online review mechanism. 2. Prepared standalone recording worksheets for BET/Sterility/Bioburden forms and removed recording worksheets issued from QA.

Reduced the Environmental monitoring samples of microbiology lab through prospective risk analysis and developing rationale for sampling locations.

Established Incident rate of environmental monitoring samples of classified rooms.

Executed gap assessment for GxP, upgraded existing equipment PLC and HMI/Software based on category wise in line with 21CFR compliance.

At Mylan Laboratories Limited

Oncology Injectables manufacturing area qualification, Microbiology Lab renovation and new lab setting as per regulatory norms by close monitoring of project schedules, budget control, execution challenges etc.

Installation, commissioning and qualification of Microbiology lab equipments post renovation.

Played key role in successful completion of media fills followed by commercial manufacturing.

Completed all cyclone affected area works and restoration lab for operation in 30 days time.

Participated in facility layout, pressure zoning, men & material movement layouts review and finalization in line with current GMP regulations for an oncology Bulk API facility.

Incorporation / implementation of corporate Quality procedures and maintaining as per regulatory guidelines.

Successfully implemented online environmental monitoring documentation software system (MODA), Lab-ware LIMS thereby eliminating paper based system.

Active investigator in Media fills simulation failures and proposed CAPA appropriately.

Involved in CCIT using Microbial Ingress method.

At Fresenius Kabi Oncology Limited

Responsible for performing Site manufacturing investigations and initiation of CAPA as per requirements.

Performing Quality Audits at manufacturing locations, ensuring compliance of microbiology lab.

Preparation of new Standard operating procedure and validation protocols.

Facing regulatory audits and internal audits.

Review of process validation protocols, quality documents for regulatory submissions.

Review of Media fill simulations process, categorization of interventions and implementing in media fill program.

Involved in root cause identification by FMEA methods for various critical problems such as environmental monitoring excursions, media fill failures.

Managed team of 25 members with high competency and efficiency.

Professional Experience

Since Apr’17

Pfizer Healthcare limited, Vizag as Manager-Generic drugs manufacturing facility (Injectables).

Facility: manufacturing of Generic drugs liquid Injectables, Water for injection, Terminal sterilization products-Total 6 lines.

Sep’14 – Apr‘17

Mylan Laboratories Limited, Visakhapatnam, Sr.Manager (Head Microbiology).

[Facility: manufacturing of Cytotoxic Injectables, active pharmaceutical ingredients production of Cytotoxic Product]

Feb’13 – Sep’14

Fresenius kabi Oncology Ltd, Baddi as Asst.Manager

[Facility: Manufacturing of oncology Sterile Injectables, Tablets, Capsule.]

Key Impact Areas

1.SME Microbiology

2.GMP Audits & compliance

3.Analytical quality assurance

4.Root cause identification

6.Process/Cleaning Validation

7.People management

8.QMS handling

9.Operational excellance

10.Equipment and facility qualificaitons

Exposure on various Dosage forms

1.OSD Tablets

2.Liquid Injectables

3.Dry powder Injectables

4. Lyophilized Injectables

5.Active pharma ingredients

Soft Skills

1.Decision making

2. Communications

3.Motivation

4.Analytical skills

At Nectar Life Sciences Limited

Contributed in the development and setting of new microbiology lab for sterile API facility.

IQ, OQ.PQ of microbiology lab equipments/Instruments for new lab.

Headed microbiology department with 15 members for 4 Sterile API facilities with compliance.

Completed EDQM, Customer Audits successfully.

Training all Microbiology team members for Aseptic techniques, gowning procedures as per CGMP.

Responsible for Site QMS in change management stream.

At Orchid Pharmaceuticals Limited

Performed Bio-burden, MLT, BET tests for incoming raw material, Intermediate, stability and finished product samples. Performed sterility testing for finished product, stability samples.

Performed environmental monitoring of Aseptic and controlled areas. Performed Non-Viable monitoring in classified areas.

Performed Media preparation, GPT, Media stock maintenance. Performed Culture isolation, maintenance storage. Identification tests(VITEK)

Performed water sampling, analysis (WFI, PW, Raw, Potable water).

Performed Steam heat sterilizer validation, Incubator, deep freezer validation.

Involved in Aseptic media fill simulations, Interventions. Involved in HVAC system area qualification. Performed Hold time study of sterilized media/articles. Microbial Recovery study by RODAC/Swab method.

At J.K.Pharmaceuticals Limited

Performed Penicillium seed culture inoculums for large scale fermentation production.

Screening of seed inoculums for productivity, sterility & viability.

Performed Sterility checking of Penicillium culture samples from Germinator, Pre-Fermentor & Fermentor vessels at different time intervals & as per schedule.

Monitoring Morphological characteristic of penicillium culture microscopically.

Performed MLT testing of Raw material.

Dec’11 – Feb’13

Nectar Life sciences, Punjab as Asst.Manager.

[Facility: Manufacturing of Sterile Cephalosporin API’s(Antibiotics), Tablets – Total 4 blocks]

July’06 – Dec’11

Orchid Pharmaceuticals Limited, Tamilnadu as Executive.

[Facility; Manufacturing of Sterile Cephalosporin API’s (Antibiotics) Total 5 blocks.

Nov’04 – June’06

Asian paints Ltd, Tamilnadu as Officer.

Mar’02 – Oct’04

J.K.Pharmaceuticals Ltd, Tamilnadu as Microbiologist. Bulk API Fermentation plant.

Career Timeline

Currently working with M/s Pfizer, Vishakhapatnam as Group lead since Apr 17th onwards

KEY RESULT AREAS

Maintaining close coordination between production, supply chain management, sourcing, validation and other functional divisions for smooth functioning of Microbiology lab in line with Pfizer Quality standards.

Working with Global GLIMS team for implementation of LIMS software in microbiology lab, concept finalization, testing worksheet template design, designs review URS review and approval in line with Pfizer global LIMS experts.

Planning and scheduling testing/release/review activities on time and maintaining Turn around time (TAT).

Tracking batch release progress there by submission of microbiology reports, investigation closures etc enabling release of batches on time.

Proactively manage changes in testing plan, identify potential crises, and devise contingency plans.

Proactively planning the validation & calibration of microbiology equipments/instruments and providing the status reports to the management and troubleshooting the problematic areas.

Identifying the needs of team members and providing support on time. Setting the goals of team leaders/members and ensuring the said goals are achieved in the committed timeline.

Develop best laboratory practices and tools for continuous improvement.

To ensure microbiology procedures meets industry leading quality standards and regulatory guidelines.

Timely closure of CAPA, investigations as per target dates & as per agreed timelines.

Adhering to plant EHS, safety policies, statutory laws and global in-house policies

Develop capex budgets and materialize the requirement interns of business requirement

Closer coordination with internal customers for equipment and facility qualifications execution as per time lines

Review team performance and work out improvement strategies in line with current regulatory challenges

Ensure contractual team training and upgrade their skill level as per current SOPs and standards.

Education details

M.SC. Microbiology from Madras University, Chennai

M.Phil Biotechnology from Bharathidasan university, Trichy

MBA – Human resource Management from IGNOU, Delhi.

Targeting senior-level assignments as Quality Microbiology Lab Head /Quality Assurance, Sterility assurance Lead roles in Pharmaceutical / Biotechnology / Healthcare /MFCG industries

Arun S M

MANAGER – GROUP LEAD at PFIZER

ac9ujv@r.postjobfree.com 994*******/950-***-****

Team Building & Leadership

Analytical

Mylan Laboratories Limited, Visakhapatnam. Cytotoxic Injectables and API. USFDA Approved

Fresenius kabi Oncology Ltd. Sterile Injectables. USFDA, MHRA Approved

Orchid Pharma Limited, Hyderabad Sterile API Facility.

USFDA,MHRA Approved

Asian paints Limited, Paint mfg plant

ISO Approved Plant

July’06

Dec’11

Mar’02 Oct’04

Dec’11

Feb’13

Feb’13

Sep’14

Sep’14

Apr’17

Nov’04 June’06

J.K.Pharmaceuticals Limited, Tamilnadu, ISO approved plant

Nectar Life sciences Limited, Punjab. Sterile API, EDQM Approved Plant

Personal Details

Date of Birth:20th May 1979

Languages Known: English, Hindi & Tamil

Address: Flat no: 207, Shanti nagar, Vasavi towers, Aganampudi,Vishakapatnam, Andhra Pradesh.

Passport No.: L3531986

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