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Executive / Sr.Executive - Quality Assurance - Lincoln Pharma

By: Pharma Jobs | Views: 3996 | Date: 15-Jul-2013

Lincoln Pharmaceuticals Limited - www.lincolnpharma.comLincoln Pharmaceuticals Limited is one of the fastest growing players in Pharmaceutical Industry focusing on Generics & Specialty products, providing products to customers in more than 50+ countries and territories.The company maintains one of the industry" broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline.With a workforce of more than 1000, Lincoln has attained leading positions i

Executive / Sr. Executive - Quality Assurance

by Lincoln Pharmaceuticals Limited in Ahmedabad

 Lincoln Pharmaceuticals Limited

Job Description

  • Prepare and review controlled documents; Monitor distribution, revision, retrieval, archival and destruction of controlled documents
  • Participate and provide inputs in investigations related to OOS/ deviations/ customer complaints/ OOT/ incidences/ return goods/ recalls in collaboration with cross functional team
  • Monitor the online compliance activities during manufacturing operations Provide line clearances after satisfactory review
  • Plan for in-process sampling as per production schedule
  • Monitor the plant activity and prepare necessary documents with respect to change control action plans
  • Follow up on approved change control procedures to ensure execution is in line with action plan
  • Prepare validation documents and conduct first level review of the same
  • Monitor the execution of validation/ qualification processes at each stage of manufacturing
  • Compile the vendor evaluation data/ documents
  • Conduct first level review of the relevant documents (batch production records, analytical raw data, packaging records, label records etc.) related to QA release
  • Prepare and review the APQR report, Analyse and summarize the data collected in APQR preparation, Prepare recommendations based on APQR evaluation
  • Engage with employees, Direct and guide team on departmental issues, Provide on-job training to team members
Salary:

Best In The Pharmaceutical Industry

Industry:

Pharma / Biotech / Clinical Research

Functional Area:

Production, Manufacturing, Maintenance

Role Category:

Production/Manufacturing/Maintenance

Role:

Quality Assurance/Quality Control Executive

Keyskills:

QA, Quality Assurance, IPQA, Validation, OOT, OOS, Line clearance

Desired Candidate Profile

Education:

(UG - B.Pharma - Pharmacy) OR (PG - M.Sc - Any Specialization, M.Pharma - Pharmacy) AND ( Doctorate - Doctorate Not Required)

1. The candidate must be Graduate/Post Graduate in Pharmacy or Post Graduate in Science from recognized university/institute.

2. The candidate must have 3-7 years of relevant experience of Quality Assurance activities with reputed pharmaceutical players.

Key Competencies Required:
- Application knowledge of regulatory requirements;
- Knowledge of qualifications and validations
- Knowledge of Quality tools including root-cause analysis, investigations
- Knowledge of Quality Management System
- Knowledge of cGMP requirements
- Knowledge and experience of regulatory audits i.e. USFDA, MHRA, TGA, MCC, ANVISA etc.

2. Candidate must have faced various Regulatory or Semi Regulatory Audits as a QA Representative.

3. He/She must possess very good communication and presentation skills.

4. The candidate must be self motivated, self driven, enthusiastic and highly passionate to contribute and achieve the desired goals of the organization

5. Must be well conversant with MS Office and SAP & ERP

6. Local candidates from Ahmedabad and Gujarat will be given first preference.

7. Fresh candidates do not need to apply as this position is designed for experienced professionals.

Kindly send your updated CV highlighting your key contributions and achievements on bimalvyas@lincolnpharma.com.


Company Profile

Lincoln Pharmaceuticals Limited
http://www.lincolnpharma.com
Lincoln Pharmaceuticals Limited is one of the fastest growing players in Pharmaceutical Industry focusing on Generics & Specialty products, providing products to customers in more than 50+ countries and territories.

The company maintains one of the industry" broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline.

With a workforce of more than 1000, Lincoln has attained leading positions in key Semi Regulated Markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.

The Manufacturing Facility is approved by WHO-GMP, ISO-9002 and other Semi Regulatory Approvals and aiming to get Regulatory Approvals such as MHRA, EU-GMP, TGA and USFDA for both Solid Dosage Forms & Small Volume Injectables (SVPs) in nearest future.


Contact Details
Recruiter Name:

Mr. Bimal Vyas, Human Resources

Contact Company:

Lincoln Pharmaceuticals Ltd

Address:

Lincoln House, B/h Satyam Complex, Science City Road, Sola, AHMEDABAD,India

Email Address:

Telephone:

+91-79-6777-8011

Reference Id:

Sr. Executive-QA


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Comments
Praveen Rajpurohit  |  06-Aug-2013 13:24:27 IST
i m b.pharma fresher i want job your cmpany in Q.A department
Rohit panchal  |  27-Apr-2014 13:18:03 IST
I have experience as pharmacist in Apollo pharmacy. I looking for job in QA department in your company.
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