Quality Assurance Associate

BINITA PARIKH

Toronto, ON M*V *R* 647-***-**** **************@*****.***

PERSONAL PROFILE

Bachelor of Pharmacy degree with more than 10 years of experience in pharmaceutical industry

Extensive experience in Quality assurance and Documentation

Strong collaboration skills with internal departments in a professional manner

Ability to manage multiple projects using project management and time management skills

Flexible and eager to accept challenges and responsibilities with positive and supportive attitude

Efficient and friendly in supervising teamwork with excellent problem-solving skill

Excellent written and verbal communication and interpersonal skills

Highly attentive to details and ability to work with high degree of accuracy

Outstanding leadership ability to provide guidance and training to staff

Proficiency in MS office, Microsoft Dynamic AX, SharePoint, Outlook KEY COMPETENCIES

Quality Assurance / Management

CAPA/Non-conformance

Documentation

QMS, SOP, cGMP and GDP

Analytical and Physical Test Methods

Pharmacopoeias

Line Clearance

Qualification of Equipment

Calibration and Validation

Complaints/Investigations

Logs and Batch Process Records

Data Management and Reporting

ACCOMPLISHMENTS

Acted as core team member for QA team for UN projects delivering goods as per regulatory requirement and achieved annual business increase from UN by 10%

As part of business nature and scope, effectively communicated to the suppliers and clients of more than 12 different countries and maintained relation

Successfully handled around 300 nos. of Healthcare and Medicine projects for various countries

Collaborated closely with process team and suggested process improvement to strengthen the quality system

RELEVANT SKILLS & EXPERIENCE

Documentation Supervisor Law Office Ramesh Patel. Toronto Current

Complete title searches and notify the lawyer of any encumbrances or other issues with the title

Review deeds, affidavits and agreement of purchase and sale

Manage and prepare important documents for real estate transactions and closings, such as tax certificates and confirmation of insurance, and write cheques for disbursements

Register mortgages and usually the point of contact when clients have questions about their closing

Assist the lawyer in preparing sponsor letter for visitor visa, Will, Power Of Attorney, Affidavits

Communicate with clients, other party solicitor, Real Estate brokers for existing deals and issues

Filling, Archiving and Managing documents related to Real Estate, Family transfer, Mortgages etc. PROFESSIONAL EXPERIENCE

Quality Assurance Supervisor Mifamed Medical Pvt. Ltd. India 2008-2018

Completed the internal Quality documentation system related to product, regulatory approvals and certificate as per GMP guidelines in timely manner

Trained the department for any changes and updates in guidelines, SOPs, Upgrade of the system

Managed presentation of the team with project diagram and process mapping

Supported customer complaints and other investigations by logging complaints and gathering relevant information and issue final reports

Proven excellent administrative support to the team when required BINITA PARIKH

Toronto, ON M9V 1R9 647-***-**** **************@*****.*** Professional Experience continued

Maintained complains and investigations data bases and issued reports to management as required

Analyzed complains and investigations records and issued trending reports

Identified recurring non-conformances and taken appropriate actions and kept management informed

Provided assistance to CAPA and Non-conformance investigations programs as needed

Implemented key process improvements to strengthen internal quality system and elevated GMP requirements

Participated and completed training assignments successfully and maintained training records

Assisted in hosting internal and external inspections and prepared documents and reports

Escalated and responded to Non-conformance or Queries and provided positive solutions

Assured that out of specifications and deviations were closed before QA release and final shipment

Ensured that stability protocol and studies as per the ICH guidelines Quality Assurance Chemist Lincoln Pharmaceutical Ltd. India 2001-2006

Ensured that in-process and Finish products quality controls were performed during entire manufacturing operations and results were satisfactory according to the cGMP requirements

Prepared composite samples for laboratory and retentions, delivered to required area(s) and controlled storage and disposition of reserved samples

Concerned with Documentation, Validation & Calibration of various Instruments & Equipment’s

Initiated, planned and completed change control requests

Delivered CAPA and followed up for completeness and effectiveness

Provided administrative support to the department as and when needed

Supported for deviation investigation, root cause analysis and closure

Reported the product, process and system risks—and kept management informed

Reviewed and Approved production batch records before release according to cGMP requirements

Updated QA documents including SOPs as per the define time line and as per the audit requirement

Assisted in hosting internal, external audits and regulatory inspections from various regulatory bodies

Documented outcome of regulatory inspections and assisted for responses to complete and managed to verifiable closure

EDUCATION & TRAINING

Bachelor of Pharmacy – Gujarat University, India

(Course by Course Assessment with WES equivalent to Bachelor Degree) BLS / Standard First Aid with CPR C and AED, Rescue 7, Toronto, ON Bridge to Healthcare Alternatives, JobSkills, Toronto, ON Good Distribution Practice, Bureau Veritas, India

Communicate to Win, Ahmedabad Management Association, India VOLUNTEER EXPERIENCE

YMCA Employment and Immigrant Services, ON 2019 - Present

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