Jobs Opening for below various Pharmaceutical Field for B.Pharma, M.Pharma, B.S.C. , M.S.C.QC MicroQA - QMS Injectable (Vial / Lyophilisation )QA - Validation InjectableQA - IPQA InjectableManufacturing InjectableRegulatory Compliance InjectableProject ManagementPackaging & Development (R&D)
Pharma Jobs QA,QC,Production,Regulatory,Packaging in Amneal Pharmaceuticals Co. Pvt.Ltd
Jobs Opening for below various Pharmaceutical Field for B.Pharma, M.Pharma, B.S.C. , M.S.C.
QC Micro
QA - QMS Injectable (Vial / Lyophilisation )
QA - Validation Injectable
QA - IPQA Injectable
Manufacturing Injectable
Regulatory Compliance Injectable
Project Management
Packaging & Development (R&D)
Job Synopsis
Vacancies at Injectable SEZ - Amneal Pharmaceuticals, Ahmedabad
Company: Amneal Pharmaceuticals Co. I Pvt. Ltd
Experience: 3 to 8 yrs
Location: Ahmedabad
Job Description
Vacancies at Injectable SEZ
We are having following vacancies in Injectable SEZ for our Matoda Facility based at Ahmedabad:
Please find the detail job specification for all the above mentioned vacancies
Job Specification: QC Micro
Designation: Officer / Executive / Sr. Executive
Qualification: M.Sc Microbiology
Experience: 2-6 Years
Desired Profile:
Responsible to perform a full-range of Microbiology testings.
Should have sound knowledge and experience in Environmental Monitoring (Air Sampling, Settle Plate, Surface Monitoring, Personnel Monitoring)
Must have knowledge of Validations of method, equipments .ie. Autoclave, LAF, Area, Water system . Bio Assay, BET Test, Sterility Testing, MLT, etc
Job Specification: QA - QMS Injectable (Vial / Lyophilisation)
Designation: Executive / Sr. Executive / Assistant manager
Qualification: B. Pharma / M.Pharma
Experience: 3 7 Years
Desired Profile:
Must have US / EU regulatory market injectable experience in QMS.
Should be sound in investigation of deviation and have good deviation drafting skill.
Should have knowledge of Quality Risk Management. Risk assessments and risk mitigation through appropriate tool.
Responsible for Self-inspection. Its compliance and report preparation.
Evaluation of Change Control. Verification of effectiveness of the changes.
Should have knowledge of laboratory OOS investigation and drafting of OOS.
Handling of CAPA and CAPA Tracking system.
Should have experience of contract service agreement.
Preparation of QMS trends.
Preparation of quality matrix.
Should have an experience of document and data control.
Impact assessment of the new or revised documents on site. Communication of the same to the cross functional department.
Job Specification: QA - Validation Injectable
Designation: Executive/ Sr. Executive
Qualification: M.Sc / B. Pharma / M.Pharma
Experience: 3-6 Years
Desired Profile:
Must have Exposure in Validation Activity of Injectable.
Initiate and execute validation studies throughout the facility
Provide the input of new equipment with respect to GMP aspects
Document controlling of validation protocol and report.
Ensure the compliance as per the requirement of stipulied time.
Co-ordinate the internal and external party for validation related activity.
To perform the validation job in coordination with QC, production and Engineering department.
Ensure execution of DQ, IQ, OQ and PQ activity of the new equipment along with documentation in place in time.
Verification of HVAC and water system document periodic.
Prepare (protocol and report), execute and verify aseptic process simulation by media fill.
Audit Compliance review to validation activity to be compliance stipulated time.
Hold time study of cleaned equipments.
Review of disinfectant validation report.
Controlling of streamlined validation activity in coordination with Q.A. manager and validation officer.
To able to prepare the protocols and reports and execution of process validation, media fill validation and cleaning validation studies
Good English communication skill (reading and writing)
Knowledge of PDA technical reports, and other guidelines of Injectable(USFDA September 2004)
Job Specification: QA - IPQA Injectable
Designation: Officer / Executive / Sr. Executive
Qualification: B.Pharm / M.Pharm
Experience: 3-6 years
Desired Profile:
In process quality assurance activities (IPQA) at theinjectable production floor.
Review of Batch Manufacturing and Batch Packing records.
Preparation of Annual Product Quality Review (APQR).
Issuance of batch manufacturing and batch packing records
To give line clearance during manufacturing, dispensing and packaging stages
To release the batch as per review of BMR
To collect in process samples at various stages of batch manufacturing and packaging
To collect the control samples and FP samples during the batch execution
Job Specification: Regulatory Compliance Injectable
Designation: Officer / Executive / Sr. Executive
Qualification: B.Pharm/ M.Pharm
Experience:3-6 years
Desired Profile:
Regulatory filings ANDAs, MAAs (national, MRP/ DCP), response to questions from Authorities, annual reports, changes/ variations etc.) in regulated markets of sterile dosage forms.
To strategically plan the filings for US/EU and plan for the resources to meet the defined timelines for submissions.
To liaise with the Regulatory Authorities for submissions, query responses etc.
To co-ordinate with various functions within R &D and manufacturing locations for data generation for submissions and provide regulatory guidance
To ensure quality dossier preparation/ submissions for the regulated markets (US/EU) as per timelines.
To provide support for the Regulatory Authority Audits to the manufacturing locations.
Job Specification: Project Management
Designation: Executive / Sr. Executive
Qualification: B.Pharm / M.Pharm
Experience: 3-6 years
Desired Profile:
Product development through the entire product cycle from strategic and tactical perspectives
A well-developed understanding of the generic pharmaceutical development process acquired through a minimum of 3-6 years of industry experience in at least one of the following areas: drug formulation development, clinical strategy development, or project management.
Must have the ability to work with external vendors such as CROs, CMOs, consultants, material vendors and other external third parties to drive a strong development program.
Needs to have a strong understanding of the US generic pharmaceutical industry and additionally possess understanding other major global markets as applies to the generic pharmaceuticals.
Job Specification: Packaging & Development (R&D)
Designation: Executive/ Sr. Executive
Qualification: M.Sc / B. Pharma / M.Pharma / PG Diploma in Packaging
Experience: 5 8 Years
Desired Profile:
Packaging Development of Injectable / Ophthalmic for Regulatory market.
Dose devices, Compliance pack for both products
Packaging development of both dosages with respect to Quality by design.
Primary, Secondary and Tertiary packaging development of both dosages forms
Preparation of STP and Spec for packaging materials and performing test to evaluate the Packaging materials.
Identification & determination of suitable packaging change part, packaging components as well as development of new product art work, bill of material, batch packaging record.
To solve the packaging related problem suggested by marketing or production.
Development of moulds & trials for packaging material.
Designing Skills:
AUTOCAD
Job Specification: Manufacturing Injectable
Designation: Executive / Sr. Executive
Qualification: B.Pharm / M.Pharm
Experience: 3 6 Years
Desired Profile:
To observe & follow practices as per standard operating procedures of the production department
To be aware and responsible for achieving quality objective and fulfilling the requirements of the quality of the companys service by means of applicable quality procedures as per cGMP.
To manufacture and fill the batch in accordance with laid down quality standards.
Completion of all the records related to production area.
To perform and ensure that required in process tests are performed as per requirement and set standards.
Please note, preference will be given to those who are having experience in USFDA regulated plant.
Role: Other
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: Other
Keywords: QC, QA, Regulatory, project, packaging, injectable, amneal, pharmaceuticals, ahmedabad, Microbiology, BET, MLT, Sterility Testing, AUTO CAD
Desired Candidate Profile
Education: (UG - B.Sc - Any Specialization, B.Pharma - Pharmacy) OR (PG - M.Pharma - Pharmacy, M.Sc - Any Specialization) OR (Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required)
Company Profile
Amneal Pharmaceuticals Co. I Pvt. Ltd
We Amneal Pharmaceuticals Co. (I) Pvt. Ltd. represent a new generation of generics. Amneal Pharmaceuticals, L.L.C. has grown from a small OTC contract manufacturer to a high-quality producer of both solid and liquid generic prescription pharmaceutical products. Through strategic partnerships, focused acquisitions, and innovative R&D, we are swiftly progressing toward our objective of becoming one of the nation's top-10 generic pharmaceutical companies. Our company started in Paterson, New Jersey and remains headquartered there today with new facilities sprouting up all over the globe. We now operate in Glasgow, Kentucky; Branchburg and Fairfield, New Jersey; Ahmadabad, Gujarat, India; and Long Island, New York. Amneal continues to manufacture all of our own products in the United States under the strictest of guidelines.
Regards,
Ms. Ruchi Lal
Human Resource
M: 8128668291
Amneal Pharmaceuticals Co. I Pvt. Ltd