Assistant Manager/Executive - Quality Assurance - Pharma (6-8 yrs)
About our client:
- One of the leading Pharmaceuticals/Biotech Groups of India
- Known as one the best Pay Master in Pharma / API Industry
- Job title : Asst. Manager /Executive-
- Job location: kalol (near Vadodara)-
Educational qualification: M.Sc. (Chemistry) or B.Sc. (Chemistry) with relevant work experience in same industry.
- Around 6 year to 8 years of relevant work experience in Pharmaceuticals / API Industry.
- Should have good communication skills.
- QA batch release of manufactured 'specials'.
- Reviewing and approving new formulations, labels, shelf life extensions, repacks and in-house preparations.
- Writing, reviewing and approving Quality documentation, including validation protocols and reports, change controls and Good Manufacturing Practice (GMP) deviations.
- Assisting with customer and product queries and complaints.
- Writing, reviewing and approving Standard Operating Procedures (SOPs).
- Involvement with technical customer queries and product investigations.
- Responding to enquiries in a timely manner, giving advice on 'specials' quality requirements in order to maintain the company's reputation for customer service and technical acumen.
- Dealing with the administration and monitoring of the QMS, including change controls, GMP deviations, technical agreements, validation reports, quality risk assessments, customer complaints, periodic reviews, self inspection and external audit reports, and SOPs.
- Conducting/assisting with internal self inspection audits.
- Participating in regulatory inspections.
- Ensuring that the business complies with current and future worldwide GMP standards and requirements.
- Carrying out monthly review of Controlled Drug (CD) stock checks.
- Dealing with CD related activities on site and advising the company's Regulatory Manager of any issues with CDs.
- Delivering internal training e.g. GMP and Hygiene Induction training, Level 3 Diploma in Pharmacy Service Skills (NVQ).
- Ensuring safe working practices in accordance with COSHH.
- Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
- Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.
- Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
- Observing and complying with company Health and Safety Policies.
- Observing and complying with company Standard Operating Procedures (SOPs).
CTC: No bar for right candidate (Depends on current CTC, relevant work experience & qualification)
Key Skills : Reviewing and approving new formulations, Quality documentation,regulatory inspections
Location : Vadodara/Baroda
Required Experience : 6-8 yrs
Positions : 1