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Officer – Quality Assurance (ipqa) – 10 Opening(s)

Zydus BSV Pharma Pvt. Ltd., founded in 2005 is a joint venture company of Zydus Cadila, a global healthcare company and Bharat Serums and Vaccines Limited (BSV), one of the top 10 biotech companies in India. With a focus on niche segment of targeted therapies in the area of Oncology, Zydus BSV Pharma develops, manufactures and markets non-infringing and proprietary Novel Drug Delivery System (NDDS) of approved anti-cancer agents for global markets. Zydus BSV has engaged leading Clinical Research Organisation (CRO) and Regulatory Consultants to advice on the clinical and regulatory strategies. These service providers have proven experience in the Oncology domain. Zydus BSV also offers Contract Manufacturing capabilities based on its modern facility and experience in the Oncology injectable product manufacturing area. Zydus BSV operates in two business areas: * Proprietary NDDS (Novel Drug Delivery System) products * Contract Manufacturing of Oncology products for US and EU customers The company’s expertise lies in NDDS technologies like Liposomal and Lipid Complex products. With evidence of promising safety and anti-tumour activity in variety of cancer models in animals, the NDDS product developed by Zydus BSV has demonstrated competitive advantages that could differentiate it from the currently available dosage form.

Designation :

Officer – Quality Assurance (ipqa) – 10 Opening(s)

Job Description :

To perform the in-process checks during manufacturing, filling and Packing of the product

To Plan and perform IPQA and Sampling Activities as per BMR and BPR

To review the documents related compliance to Change control, deviation control, incident and report to shift in charge

To participate in Self-inspection as an auditor

To monitor and prepare the trend analysis report of system related utility

To ensure the compliance of current Good Manufacturing Practices in the plant

To Prepare and update the IPQA and Validation related standard operating procedures

To participate in regulatory audit and its compliance

To identify and review the investigation details in case of the deviation or non-conformance related to quality systems and procedures, initiate corrective actions and provide feedback

To compile the report of equipment qualification /Validation, Utility validation and thermal mapping study

Participate in execution of validation / qualification program. ( Autoclave , Tunnel, Filling machine , BOD incubators, Area mapping, LAFS, HVAC, Clean steam , Water system , Vial washing machine etc)

To execute and review of Process validation, Cleaning Validation and Aseptic process simulation study protocols and reports.
Desired Profile :

Experience in liquid injection manufacturing (small volume parental) is desirable.
Effective inter-personal and cross communication skills

Analytical skills:

System oriented and go getter approach

Experience 3 – 4 Years
Industry Type Pharma / Biotech / Clinical Research
Role Pharmacist/Chemist/Bio Chemist
Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
UG – B.Pharma – Pharmacy

PG – M.Pharma – Pharmacy

Doctorate – Any Doctorate – Any Specialization, Doctorate Not Required

Compensation : 2,50,000 – 4,50,000 P.A
Location : Ahmedabad, Vadodara/Baroda, Ankleshwar, Aurangabad, Bengaluru/Bangalore, Hyderabad / Secunderabad, Nasik
Keywords : IPQA Validation Documentation QMS documentation executive

Mr.Parag Chhaya

Telephone : 8511554216
Email : [email protected]